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Career postings for the Massachusetts Biotechnology Council

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    Reporting to the Global Head Drug Safety and Pharmacovigilance, the Drug Safety Physician is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing, surveilling and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicted reports, aggregate and literature reports. This physician is expected to provide interpretation and summaries of drug safety information, and provide input in the generation of safety reports (e.g. DSURs, PSURs, clinical safety assessments).  The individual will be an integral part of a group of safety professionals, and will closely collaborate with safety teams in Contract Research Organizations (CROs).  He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices,  and surveillance and risk-management practices.

     Essential Functions and Duties

    • Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports.
    • Review, analyze, and compile safety data, and present the results
    • Contribute to the generation of aggregate safety reports including periodic/development safety update reports, periodic benefit risk evaluation reports, and provide medical input for review of new or existing safety documents that ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports.
    • Support of the internal PV Operations (case processing) function.
    • Contribute to ongoing safety surveillance and signal detection efforts.
    • Contribute to the identification, assessment and communication of potential safety signals.
    • Service as a medical resource for the generation and review of clinical trial protocols, and investigator brochures.
    • Provide medical safety input into the development of Reference Safety Information.
    • Contribute to Risk Management Plans (RMPs) and/or Risk. Evaluation and Mitigation Strategies (REMS) for assigned products, and the maintenance of these documents.
    • Provide medical safety and Pharmacovigilance (PVG) expertise in-house and by consultation with outside vendors for all development programs.
    • Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents.
    • Contribute to safety and pharmacovigilance training programs.
    • Provide safety training at investigator meetings.
    • Present safety data and results.
    • Collaborate with Regulatory Affairs to ensure appropriate reporting of PVG and drug safety information to regulatory agencies and prescriber community.
    • Collaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials.
    • Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups.
    • Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.

     Skills and Experience

    • 6+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
    • Medical Degree (MD) from a recognized medical school with at least 4 years of medical practice.
    • Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
    • Demonstrated exposure to medical drug safety assessments, drug safety surveillance and monitoring activities.
    • Experience with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event summary statements.
    • Experience with safety data collection and interpretation originating from clinical trials.
    • Experience with the medical review of aggregate reports.
    • Experience with the review of Reference Safety Information for drug safety purposes.
    • Ability to build relationships and influence across disciplines.
    • Experience with data entry, MedDRA or similar coding and safety database systems.
    • Excellent verbal, written and presentation skills.

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    Procurement Analyst, Contract Management - 4 positions 


    The Procurement Analyst will be responsible for the day-to-day operations of a large contract management program encompassing the lifecycle of a contract. Responsibilities will include support, training, system administration, reporting, maintaining data integrity and enforcing company policies. 

    This program is new to the company and has not been fully implemented. The initial responsibilities of this position will include working closely with the global project team to configure the contract system, help to migrate data from the legacy tool and support change management and training across the company. 

    An ideal candidate should have strong business communication skills and be comfortable working with many types of contracts and contract systems. The ability to learn new processes and systems quickly is critical to success in this role. Any legal or procurement experience with a pharma/ biotechnology company is preferred. Any prior experience in a legal role either paralegal or legal admin would also be beneficial. 


    Primary Responsibilities 
    • Searching for existing contracts (including legacy or archived) 
    • Helping users complete contract templates 
    • Linking contract types (parent- child/ amend -change) 
    • Answering questions on contracting process/ policy 
    • Managing approval workflows and confirming correct authorization levels 
    • Supporting E-signing contracts 
    • Linking Requisition and PO to contract and reporting spend under contract 
    • Maintaining data integrity in system and proper contract storage 
    • Enforcing business rules and polices 
    • Building and updating contract templates 
    • Reporting on KPIs from system 
    • Ad-hoc reports for business, legal and procurement 
    • Master data updates including supplier harmonization and clean up 

    Requirements:

    Experience and Qualifications 

    • Proven experience with contract system administration is required 
    • Ability to learn and apply new skills quickly 
    • Knowledge of contract process, especially CLM 
    • Experience working on large global projects 
    • Familiarity of Pharma/ Biotech industry is a plus 
    • Detail oriented and recognized for attention to detail 
    • Strong interpersonal, organizational, and verbal and written communication skills 
    • Team player with a positive attitude and ability to hit the ground running 

    Education 
    • Bachelor’s degree required; concentration in business, legal or communications preferred


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  • 01/08/16--23:56: Sr Director, Media Relations
  • The Broad Institute is an amazing place - we exist to apply our deep knowledge of human genetics to empower a revolution in biomedicine and accelerate the pace at which the world conquers disease.  Through our partnerships with MIT, Harvard and the Harvard teaching hospitals we are widely recognized and respected as the "hub" of cutting-edge science in Kendall Square, the Boston-area biomedical community, and beyond. Are you interested in building out our media relations effort through a creative, strategic approach?

    Can you help explore, define and launch our stories to an audience that includes the scientific community and extends well beyond it? As we expand our Communications team, we are seeking a talented Media Relations leader who will manage media relations, build and lead a strong team, create campaigns that tell the story of leading-edge biomedical research, direct agency partnerships, and support social media.

    Job Responsibilities
    Tell the Story. You use your many talents - writing, speaking, collaborating - to tell the world how Broad is empowering a revolution in biomedicine. You creative about finding and talking to high-profile, smart reporters and editors and you have a determination and tenacity that makes you successful. Cultivate Relationships. You recognize that building relationships is central to what you do. You understand that international, national and local media are our conduit to our core audiences.

    You can create alliances with our scientists to find the breakthrough stories that inspire. You think of ways to engage with press and social media in non-traditional ways that signal our values and culture.  Build the Brand. You someone who likes to think big. You understand that this role is about telling the world a compelling story about our organization, in such a way that the right people feel drawn to collaborate with us, work with us, and help fund us. You come up with creative ways for Broad to engage with and tell our story to the world. Work Well With Others.

    You the consummate team player, working effectively in a highly-integrated team. You enjoy brainstorming with diverse talents, and know how to balance advocating your point of view with learning from others. You know when to pressure test versus when to get on board with a plan. Believe in the Mission. We a non-profit that believes in investing in the next generation of leaders to change the world. You want to contribute to an energizing, stimulating environment where global leaders in health research are working on the next big breakthrough, tapping into the smartest people and industry-leading technology to pull it off.

    Requirements
    You a talented communications leader looking to build out a media relations function. You have experience in journalism, media relations or public relations, and have excellent written and verbal communication skills. You have worked in a scientific or biomedical environment. You have demonstrated success working with scientists. You are quick on your feet but passionate about accuracy, honesty, brevity, creativity, curiosity and the best possible use of punctuation. A Bachelor Degree in science, communications, public relations or journalism is preferred. The Broad Institute will not offer visa sponsorship for this position.EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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    The Broad Institute is an amazing place - we exist to apply our deep knowledge of human genetics to empower a revolution in biomedicine and accelerate the pace at which the world conquers disease.  Through our partnerships with MIT, Harvard and the Harvard teaching hospitals we are widely recognized and respected as the "hub" of cutting-edge science in Kendall Square, the Boston-area biomedical community, and beyond.

    Are you interested in architecting, building, maintaining and improving an ancient DNA pipeline that ultimately impacts a wide variety of genetics research? As the lab is growing, we are seeking a talented and energetic software engineer/architect to chart a new course to build an ancient DNA genome factory.The position will be embedded in the Broad Institute Data Sciences and Data Engineering (DSDE) group, with 1-2 days per week at DSDE and 3-4 days per week spent in the Reich Laboratory at Harvard Medical School.

    Job Responsibilities
    - Build a pipeline for ancient DNA analysis by linking together many software components in a robust and high throughput process.
    - Push ancient DNA samples through this pipeline and troubleshoot problems when they arise, working with experimentalists and data analysis.
    - Once the pipeline is working, extend its functionality.

    Work Well With Others. You the consummate team player, working effectively in a highly-integrated team. You enjoy brainstorming with diverse talents, and know how to balance advocating your point of view with learning from others. You know when to pressure test versus when to get on board with a plan.Get Things Done.  All said and done, you deliver the goods.  You love a good technical challenge, even if it keeps you up at night. You know that your work directly impacts the analysis that will be used by wet lab biologists and that drives you to do great work.

    When a problem presents, you are already architecting the best solution.  Leaders and associates trust that you will deliver on your word.  And you do. Solve Complex Problems. You a bit like a detective when it comes to solving technical challenges.  When you presented with a problem you never take it at face value.  Instead, you dive deeper making sure you are led you to the root cause of the issue. Not only do you solve the problem but do it with precision and derive satisfaction with your craft.

    Requirements
    - You a talented software engineer and you love science.
    - You have demonstrated success working in software engineering with 1-2 years in bioinformatics.
    - A Bachelor Degree in computer science or related field is preferred.
    - You have experience working with MYSQL or related databases and scripting languages such as Perl/Python/Ruby is required.
    - A working knowledge of Java/Scala is necessary.The Broad Institute will not offer visa sponsorship for this opportunity.

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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  • 01/09/16--01:12: QC Scientist I
  • Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    The Quality Control Analytical group is seeking a highly motivated candidate to support GMP analytical testing activities for raw materials at the Andover site. The work includes various instrumental techniques including HPLC, GC, IR, UV, as well as wet chemical methods. The candidate will also be expected to support additional QC Analytical testing activities as needed.

    Responsibilities
    Key responsibilities:
    * Perform analytical testing of raw material samples.
    * Identify basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems, and participate in investigations for resolution and correction.
    * Participate in continuous improvement culture within laboratories. Utilize continuous improvement tools.
    * Record and maintain all related data and records in compliance with cGMP and quality procedures.
    * Perform laboratory support functions and maintain work area in a neat and orderly manner.
    * Perform work in a manner consistent with company safety policies and procedures.
    * Participate in company culture based programs.

    Qualifications
    * B.S. in Biology, Chemistry or related scientific discipline with a minimum of 2 years of related laboratory experience. M.S. with a minimum of 0 years of related laboratory experience.
    * Preferred laboratory experience includes GC, HPLC, FT-IR, pH, titrations, UV, and wet chemical techniques
    * Strong oral and written communication skills, technical writing skills preferred
    * Knowledge and understanding of cGMP and industry standards
    * Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
    * Experience working in cGMP USP/EP/JP, regulatory environment strongly preferred

    PHYSICAL/MENTAL REQUIREMENTS
    Normal lifting, sitting, standing and walking requirements to facilitate testing in a laboratory environment. Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL: http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS40OTc0MC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    Job ID: 27527
    Date Posted: 01/05/2016
    Location: Longwood Center
    Job Family: Technician/Technologist
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    FLSA Status: Exempt


    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

    Overview

    Research Associate

    The Robert and Rene Belfer Center for Applied Cancer Scienceis an integrative research center within Dana-Farber Cancer Institute. Our mission is to bridge academia, industry and the clinic to enhance and accelerate drug discovery & development. We work with both industry and academic partners. We apply industrial capabilities to cutting edge academic/clinical science. We partner with industry in drug discovery/development & work with industrial partners to delineate the clinical path of their therapies.



    For more information please visit: http://belfercenter.dfci.harvard.edu



    Job Responsibilities

    We are seeking a bench-level scientist to be part of a project team focused on identifying novel targets and therapies for cancer drug development.

    • Perform laboratory experiments and conduct data analysis

    • Generate reliable and reproducible data

    • Design experiments and execute on protocols; propose modification to protocols as needed

    • Maintain accurate records, write reports, and prepare presentations

    • Contribute to project team as well as overall laboratory organization and safety

    • Perform other duties as required

    Required Qualifications

    • BS/MS in biological sciences or equivalent

    • 1-2 years research experience in academic and/or pharmaceutical/biotech environment preferred (coop or internships are a plus)

    • Experience working in the fields of molecular biology, cell biology, or protein biochemistry

    • Experience with mammalian cell culture

    • Experience with routine protein analyses (Western Blotting, ELISAs, etc…)

    • Independent, self-motivated and innovative

    • Excellent written and oral communication skills
    • Outstanding interpersonal and team skills


    • Ability to excel in a goal-oriented, multifaceted and fast-moving team environment

    Additional Skills

    • Experience with animal models and in vivo procedures (i.e. anesthesia and surgery) is desirable



    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.

    Schedule

    Full-time

    40H per week

    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.

    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.




    Apply Here

    PI92659777


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    Job ID: 27536
    Date Posted: 01/06/2016
    Location: 44 Binney St, Boston
    Job Family: Clinic Admin Sup Specialist
    Full/Part Time: Full-Time
    Regular/Temporary: Temporary
    FLSA Status: Nonexempt


    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

    Overview

    Job Responsibilities

    • Under the direction of the clinical practice support management team, provides appointment scheduling ranging in complexity from one physician appointment to multiple care provider appointments in accordance with department scheduling guidelines for new and/or existing patients.
    • May provide basic information regarding the need for insurance referral(s).
    • Provides general disease or program-specific information to callers/patients within the scope of knowledge and authority.
    • Performs independent patient and outside provider call triaging and assists in directing patient flow.
    • Serves as a liaison between patient/family/provider.
    • Resolves issues directly or ensures appropriate management of call by others.
    • Recognizes emergencies and appropriately responses using standard operating procedures and critical thinking skills.
    • May be required to perform other duties as required by the clinical practice support team.
    • May provide general administrative support and coordination for all aspects of patient care for both new and/or established patients, including filing, document preparation, data entry, telephone support, etc.
    • May be responsible for scheduling numerous complex research protocols, involving extensive interaction with those associated with in-house studies, grant-funded studies and industry-sponsored clinical trials.
    • Carries out specific processes in the patient scheduling systems so that correct special billing and revenue processes function properly.
    • Participates in clinical systems training for new hires and may teach or participate in the planning of patient services refresher courses as needed.
    • May be required to perform other duties as required by the clinical practice support team.
    • Prepares disease specific reports as needed.

    Skills/Qualifications
    • Excellent customer service skills
    • Ability to multi-task
    • Prior health care experience preferred



    Schedule

    Monday - Friday, flex 8 - 4:30, 10 - 6:30 or in between

    Assignment potentially through mid June

    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.

    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

    Apply Here
    PI92669238  

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  • 01/09/16--03:45: Research Tech - Lead
  • Job ID: 27531
    Date Posted: 01/06/2016
    Location: 450 Brookline Ave
    Job Family: Technician/Technologist
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    FLSA Status: Exempt


    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

    Overview

    Job QualificationsBachelor Degree and at least 3+ years of laboratory experience is required. Experience with molecular biology skills and cell culture techniques is necessary.
    The Jnne laboratory at Lowe Center for Thoracic Oncology is searching for a motivated individual for a laboratory manager position. The person would manage and oversee daily laboratory operations and aid in cell culture based studies examining the effects of various molecular targeted agents in lung cancer. The person would work in conjunction with other technicians and post-doctoral fellows.
    Job SummaryThis dynamic opportunity would include accurate record keeping, purchasing supplies, general laboratory maintenance and operation. In addition, position would include assisting in cell culture, cloning and molecular biology assays. Applicant also needs to be organized, punctual, have good communication skills and able to work independently.

    The Jnne laboratory at Lowe Center for Thoracic Oncology is committed to genomic studies, translational research, and preclinical testing of novel treatment strategies in lung and other cancers. Specific studies include the biochemical and genetic analyses of cancer cell lines and human tumor specimens as a means to design and develop novel in vitro and in vivo therapeutic approaches

    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.

    Schedule

    Monday-Friday

    40 hours a week.

    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.

    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

    Apply Here


    PI92676863  


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    Job ID: 27530
    Date Posted: 01/06/2016
    Location: Shields Warren
    Job Family: Clinical Research Coordinator
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    FLSA Status: Exempt


    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

    Overview

    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.



    The Sr. Clinical Research Coordinator position required prior clinical research (minimum 2-3 years of applicable) experience.

    General Summary

    The Senior Clinical Research Coordinator (Sr. CRC)works within the clinical research program and supports the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The Sr. CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT).

    Duties & Responsibilities

    •Oversees the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
    •Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.
    •Prepares and or completes regulatory related reports and IRB submissions. Maintains and organizes study regulatory binders, and enters all required study data on an ongoing basis.
    •Ensures all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
    •Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
    •Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.
    •Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
    •Interacts with study participants as directed/required by the protocol and/or study team.
    •May be responsible for tissue sample work.

    Job Qualifications

    •Bachelor’s Degree required or 1-3 years of equivalent experience required.
    •Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
    •Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed.

    Knowledge, Skills & Abilities

    •Excellent organization and communications skills required.
    •Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
    •Must be detail oriented and have the ability to follow-through.
    •Ability to effectively manage time and prioritize workload.
    •Must practice discretion and adhere to hospital confidentiality guidelines at all times.
    •Must have computer skills including the use of Microsoft Office.

    Supervisory Responsibilities

    Orients and assists in training new staff.

    Patient Contact

    May have contact with patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, and/or conduct follow-up communications with patients.

    Schedule

    40 Hours Weekly, Monday through Friday.

    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.

    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.    

     

    Apply Here 

     

    PI92676960  


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    Laboratory Informatics Systems Associate

     

    Editas Medicine is a transformative genome editing company with a mission to translate its genome editing technology into a novel class of human therapeutics that enable precise and corrective molecular modification to treat the underlying cause of a broad range of diseases at the genetic level. 

    In this exciting role you will use your experience with informatics, computer science, user interface development, and data analysis to define, develop, and configure informatics infrastructure throughout the company.  You will be a super user for lab information management systems and collaborate with scientists to register, track, and analyze their experimental data.  You will identify improvements and write-up specifications in our existing JIRA systems.  You will help define data architecture and pipelines, writing code when needed (python, SQL, R, etc).  You will interface directly with our internal informatics teams and manage relationships with external vendors and consultants.  Much of the initial workload will be focused around Next Generation Sequencing, CRISPR/CAS9 genome editing detection, and bio-sample registration.

     

    Editas is a fast-paced team environment.  The position requires flexibility, creativity, and the ability to work effectively across multiple disciplines.  Excellent written and verbal communication skills are crucial.

     

    Minimum Qualifications:

    • At least 5 years’ experience developing or managing lab information systems
    • Advanced degree in bioinformatics, computer science, biology, chemistry or relevant computational discipline
    • Programming skills (e.g. Linux/Unix, Python, SQL, R, C/C++), and familiarity with database systems (Postgres, MySQL, Oracle, MongoDB, etc) and with life sciences software and algorithms
    • Experience with Amazon Web Services or hosted data analysis and management platforms will be a big plus
    • A history of achievement, demonstrated by education, publications, and work history

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    Director Ophthalmic Disease

     

    Editas Medicine is a transformative genome editing company with a mission to translate its genome editing technology into a novel class of human therapeutics that enable precise and corrective molecular modification to treat the underlying cause of a broad range of diseases at the genetic level. 

     

    Job Description

     

    The successful candidate will be integral to building and developing novel CRISPR/Cas9 technologies as therapeutics.  The incumbent will help set the strategy for Editas Medicine in the neurologic/neuromuscular therapeutic area.   Responsible for a team of scientists developing technology to be used in the treatment of ophthalmic diseases, s/he will play a key role in the successful translation of this technology into the clinic. The position requires flexibility, creativity, dynamic leadership and the ability to lead in a multi-disciplinary team, as well as excellent written and verbal communication skills, and a capacity for creativity and innovation to achieve company goals.

     

    The position will lead a team of scientists and research associates to design and advance research programs, apply innovations in CRISPR/Cas9 technologies, establish in vitro and in vivo models, and evaluate product candidates for retinopathies and other ophthalmic diseases. Additional responsibilities will include analyzing data, writing research reports and publications, and presenting results in oral format to varied audiences, including the scientific advisory board, consultants, scientists, academic collaborators and external stakeholders.

     

    Essential duties and responsibilities include but are not limited to the following:

     

    Establish work plans and timelines for the advancement of novel CRISPR/Cas9 therapeutics to the clinic

    Plan, direct and manage research efforts for a team of Ph.D. and non-Ph.D. scientists.

    Develop and manage relationships with academic advisors, research partners and CROs. 

    Help to set strategy and manage research programs from ideation to go/ no go decision points\

    Collect, review and analyze data from internal team and external collaborators.  Present results to key internal and external stakeholders, including the Executive Team and Board of Directors.

    Develop oral presentations and manuscripts of research and development projects and research results for submission to peer-reviewed journals and presentation at relevant conferences.

    Review, set and manage team goals and budget.

    Work with intellectual property team to develop novel intellectual property leading to patent submissions.

     

     

     Requirements

     

    ·       Ph.D. or M.D.  plus post-doctoral training in ophthalmologic disease biology with excellent publication record in peer reviewed scientific journals

     

    ·       Track record of advancing therapeutic programs into clinical development

     

    ·       Experience managing research groups, including PhD Scientists and Research Associates

     

    ·       Minimum of 7 years leading research programs, preferably in industry, 12 years overall research experience

     

    ·       Experience interfacing with internal and external stakeholders to execute research programs and deliver results

     

    ·       Proven presentation,  leadership skills and the ability to influence and inspire internal and external collaborators

     

    ·       Experience with IND submissions

     

    ·       Experience with nucleic acid, cell and/or gene therapy a definite plus


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    Job ID: 27532
    Date Posted: 01/07/2016
    Location: Longwood Center
    Job Family: Technician/Technologist
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    FLSA Status: Exempt


    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

    Overview

    Research Associate, in vivo

    The Robert and Rene Belfer Center for Applied Cancer Scienceis an integrative research center within Dana-Farber Cancer Institute. Our mission is to bridge academia, industry and the clinic to enhance and accelerate drug discovery & development. We work with both industry and academic partners. We apply industrial capabilities to cutting edge academic/clinical science. We partner with industry in drug discovery/development & work with industrial partners to delineate the clinical path of their therapies.



    For more information please visit: http://belfercenter.dfci.harvard.edu



    Position Summary: The candidate will be part of project teams focused on identifying novel targets and therapies for cancer drug development. He/ She will contribute hands-on to the execution of both in vivo and ex vivo PD Biomarker studies in mouse models of cancer.



    Job Responsibilities

    • Build of syngeneic, xenograft, PDX and orthotopic mouse cancer models

    • Tumor measurements by calipers and bioluminescent imaging

    • Breeding and genotyping of GEMMs

    • Micro and major surgeries in mice

    • Mouse handling and agent administration by various routes

    • Animal health monitoring

    • Mouse necropsy and tissue collection

    • Blood sampling by retro-orbital and cardiac puncture methods

    • Cell culturing techniques and subcutaneous implantation of cell and tumor grafts

    • Design studies and execute on complex mouse cancer efficacy and pharmacodynamic studies

    • Data recording, data analysis, reporting and interpretation

    • Contribute to overall vivarium organization and IACUC protocols



    Required Qualifications

    • BS/MS in biological sciences or equivalent

    • 2 years research experience in academic and/or pharmaceutical/biotech environment

    • Experience with mammalian cell culture

    • Experience with tissue lysis and biomarker analyses

    • Independent, self-motivated and innovative

    • Excellent written and oral communication skills
    • Outstanding interpersonal and team skills






    Additional Skills

    • Proficiency with in vivo databases, Graph Pad Prism and PowerPoint is desirable



    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.

    Schedule

    full time

    40hours per week

    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.

    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.




    Apply Here

    PI92676928


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  • 01/12/16--09:00: Preclinical Biostatistician
  • www.genocea.com

    Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

    Preclinical Biostatistician

    Position Summary

    We are seeking an experienced and motivated Biostatistician to join our fast-growing company to develop protein-based vaccines for the prevention and treatment of infectious diseases and cancers. The successful candidate will provide significant statistical expertise in preclinical study design and data analysis in the vaccine development and discovery research. He/She will also provide support and collaboration in analyzing large and complex data sets generated by Genocea’s ATLAS platform. The Biostatistician will have the opportunity to work on developing novel statistical methodologies and/or improve the current methodologies. He/She will contribute to the science through independent and collaborative research resulting in presentations and publications.

    Responsibilities

    • Serve as key biostatistician on preclinical study design and data analysis to identify novel protein candidates for vaccines
    • Help build statistical capabilities in vaccine development and discovery research by providing strategic input to analyze large and complex data sets from high throughput platforms.
    • Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions.
    • Develop and maintain good working relationships with discovery and clinical scientists, statisticians, computational biologists, and external collaborators to drive program decisions as part of a multidisciplinary team.
    • Proactively seek input and review from other experts within and outside the group on various projects and research activities, and share technical information when appropriate.
    • Propose opportunities for productivity improvements and implementation plans.

    Required Skills

    • Strong basis in statistical concepts and expertise in statistical methodologies such as predictive modeling and inference, machine learning methods, mixed effects models, multivariate analysis, etc.
    • Strong statistical programming skills with standard software, including R and SAS
    • Excellent communication, presentations and report writing skills, and the ability to explain complex technical details in simple language.
    • Work well in a team as well as independently, and be able to take leadership role with regard to methodological elements in projects.
    • Background in immunology and oncology would be a great asset
    • Background in analyzing high-throughput dataset would be a plus

    Education & Experience Required

    • PhD in Biostatistics or Applied Statistics
    • >1 year relevant academic/industry experience on topics related to immunotherapy, oncology, drug discovery, clinical genomics or other applications

    To apply for this position, please CLICK HERE


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    GENERAL SUMMARY/OVERVIEW STATEMENT:

    The mission of the Center for Clinical Investigation (CCI) is to strengthen the culture for clinical research at the Brigham and Women’s Hospital, by building services helpful to clinical investigators and facilitating the success of individual investigators. CCI is organized into 6 programs, each led by a BWH faculty member. 

    Working independently and under supervision from the Senior Project Manager and Administrative Directors provides support to clinical research studies.  May be responsible for the following activities: overseeing and guiding the work of more entry level staff, and assisting on regulatory responsibilities of multiple research studies supported by the CCI.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:

    Coordinate and assist with all protocol submissions, preparation and submission of regulatory documents Assist with the submission regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, etc. to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA). Assist with the maintenance of various regulatory records and databases with information related to study recruitment, subject enrollment, and study completion. Maintains or assists in the maintenance of records on each study to ensure regulatory compliance with Partners policies as well as federal and ICH/GCP guidelines. Assist with preparation for and participate in monitoring visits by sponsor Train more junior staff on regulatory process and procedures Develop and document standard procedures for managing studies supported by CCI. Review and monitor progress of research studies Meet regularly with Medical Director, Manager, and CCI Administration. Initiate and monitor study start-up activities Participate in ongoing training and educational activities within CCI.  Participate in educational offerings and activities to maintain up to date knowledge of local and federal regulations and guidelines Responsible for providing support for CCI program development. Other duties as assigned

    QUALIFICATIONS:

    Bachelor’s degree required. 2 -3 years of work experience in clinical research, preferably actively coordinating human research trials. 1 year of regulatory compliance experience (FDA, IRB etc) preferred.

    SKILLS/ABILITIES/COMPETENCIES REQUIRED:

    Thorough knowledge and understanding of ICH/GCP guidelines and methodologies Sound independent judgment Excellent written and oral communication skills Ability to analyze information and problem solve Maintain confidentiality of information Demonstrate good decision-making and judgment Strong attention to detail and follow-through skills Demonstrated organization and time management/prioritization skills with the ability to work independently are required. Ability to effectively train and mentor

    Brigham and Women’s Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.

     

    If you are interested in this position please apply to Job ID# 3008176 to the link below:

    http://www.brighamandwomens.org/About_BWH/Careers/external-candidate-job-listings.aspx?sub=0


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    Primary Duties:
    * Manage the Global Medical Communications Team, Neurosciences
    * Oversee the development and implementation of medical communication plans in Neuroscience. Personally develop and implement medical communication plans for one or more disease areas / assets in Neurosciences. Manage medical aspects of the global Commercial - Medical - Legal - Regulatory (CMLR) materials review process.

    Responsibilities:
    20%
    Manage the Global Medical Communications team in Neurosciences
    Oversee routine activities within the Global Medical Communications team for Neurosciences.
    * Coordinate with Human Resources / Talent Management to recruit and retain Global Medical Communications team, Neurosciences. Monitor team performance in terms of goals and delivery of medical communications plans and identify and foster areas for development
    * Actively manage team allocation to ensure quality and timely delivery against medical communication plans. Communicate resourcing requirements to Head of Global Medical Communication

    25%
    Oversee the development and implementation of medical communication plans in Neurosciences
    * With the Neuroscience Medical Affairs team, define medical communication requirements for each disease area / asset
    * Support Neurosciences Global Medical Communication Leads and Project Leads with the compliant definition and implementation of each disease area / asset plan.
    * Coordinate with Head of Global Medical Communications and other Global Medical Communications Group Leaders to identify and share medical communication best practices
    * Collaborate with Head of Global Medical Communications and procurement business partners to manage agency contracting and sourcing as needed for plan implementation
    * Oversee development of product/disease area Global Medical Communication plans for each priority pipeline and in-line products/disease area
    * Coordinate with Global Medical Teams and International Medical Affairs to define appropriate medical communication platform solutions to support product/disease area strategy implementation across geographies, including, e.g. Medical congress planning and delivery

    35%
    Personally develop and implement medical communication plans for one or more disease areas / assets in Neurosciences
    * Collaborate with the Global Medical Team for one or more disease areas / assets to translate medical strategy into medical communication objectives and activities
    * Define and oversee implementation of the medical communication plan for each disease area, including for example, medical materials (print and virtual), event support and disease state education

    20%
    Manage medical aspects of assigned global Commercial - Medical - Legal - Regulatory (MLR) materials review process and non-promotional materials review process
    * Manage day-to-day medical implementation and optimization of the Shire CMLR process for promotional materials and review process for non-promotional materials within Neurosciences by the Global Medical Communications team, including performance monitoring to improve service levels, resource utilization and compliance
    * Conduct medical review for one or more disease states / assets

    Education and Experience Requirements
    * A relevant healthcare degree is required. A medical or scientific degree (MD, PharmD, PhD, MS or RN) is preferred.
    * >6 years of experience in the biopharmaceutical industry, preferably within a matrix structure
    * >4 years of experience within medical affairs roles (e.g. Medical Science Liaison, Medical Information, Medical Communications, Medical Education, Publications)
    * Experience leading teams is preferred
    * Experience managing vendors and complex projects is required
    * Strong knowledge of medical communications approaches and best practices is required
    * Familiarity with regulatory and legal guidelines regarding medical communications strategy and execution

    Other Job Requirements
    * Availability to travel approximately 20% of time
    * Availability to participate in early or late meetings/teleconferences.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjQ4NzU5LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 01/12/16--09:43: Sr. MSL (Pacific Northwest)
  • Primary Duties:
    * Serve as a field-based extension of the Therapeutic Area Medical Strategy Group
    * Systematically identify the scientific exchange needs of Key Opinion Leaders (KOLs), investigators and other stakeholders in patient care, establish strong professional relationships, provide credible scientific expertise and serve as a liaison to Shire Global Medical, Global Clinical and external partners
    * Ensure compliant communication and education of Shire's marketed and emerging product portfolio to meet the educational and professional needs of Shire's key customers
    * Responds effectively to requests for scientific exchange
    * Support design and implementation of scientific programs with external experts and Global Medical Affairs (GMA)
    * Support local team disease area and product knowledge through scientific training
    * Maintain personal expertise in relevant disease areas and MSL best practices
    * The Senior Professional 2 Level will have additional management, leadership and project responsibilities internal and external to GMA

    Responsibilities:
    50%:
    KOL Relationship Management
    * Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand Shire's research, advisory and educational partnership opportunities
    * Ensures high standard of professionalism to develop and maintain "peer-to-peer " scientific relationships with key thought leaders in healthcare, academia, payer, and government organizations per strategic territory plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
    * Ensures appropriate scientific exchange with HCPs by fostering fair and balanced medical and scientific communications that are not misleading
    * Provide scientific liaison support to Investigators currently involved in Shire's interventional or observational studies and investigator sponsored trials
    * Serve as a liaison between HCPs and Shire medical affairs
    * Participate in KOL planning
    * Maintain KOL plans and update medical customer relationship management system in a timely, accurate and compliant manner

    Contribute to Shire's Strategic Medical Strategy
    * Provide scientific input and participate in local medical and cross-functional initiatives

    15% :
    Mentoring and Project Management Activities
    * Generates new ideas and constantly searches for novel applications of development plan strategies and tactics
    * Fosters teamwork within the area to achieve strategic objectives
    * Encourages an environment leading positive performance among colleagues and internal customers, and supports both individual and overall program success
    * Is a mentor for other MSL team members
    * Assist and augment training development of regional field-based MSLs

    10% :
    Effective and Compliant Dissemination of Data
    * Respond within defined timeline and quality standards to unsolicited inquiries from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
    * Support development of appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
    * Presents clinical and disease state information to a variety of audiences, including KOLs, Medical advisors, formulary/decision makers and other HCPs

    Education and Experience Requirements:
    * An advanced degree in life sciences (MD, PharmD or PhD or equivalent) is required
    * Has an established track record of effective and influential oral presentations within the healthcare profession
    * Demonstrative therapeutic research/experience or substantive patient care experience is required (3 years minimum)
    * Require minimum 36 months of experience as a field MSL
    * Demonstration of expertise in key skills and competencies

    Other Job Requirements:

    * Frequent travel is required. Availability to travel approximately 40-70% of time
    * Availability to attend meetings on holidays and weekends
    * Clean and valid driver's license

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6Ljc2ODIyLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Duties :
    Primary objective of Manager, Business Operations GHEORE is to minimize non-scientific demands on our technical staff. The successful candidate will have broad responsibilities including by not limited to preparing contracts, processing & tracking Purchase Orders (POs), Statements of Work (SOWs), and Service Agreements for the GHEOR and epidemiology teams. Works with internal IT to execute against site and process improvements for the applicable systems. Work with the VP of GHEORE to enhance process efficiencies

    Responsibilities:
    The responsibilities of the successful candidate are expected to evolve with the needs of the department and his/her professional development goals. Current responsibilities will include:

    20%: Decision Support
    * Identify and execute against opportunities for improvement of related to GHEORE tracking systems, reporting and other processes.

    60%: Support Business Processes
    * Serve as member of the GHEORE Leadership Team.
    * Provide operational perspective to discussions.
    * Capture and distribute minutes of GHEORE Leadership meetings.
    * Liaise with GHEORE stakeholders, Procurement, and Legal to facilitate efficient internal vendor-associated communication and external vendor management and training.
    * Support procure-to-pay process through coordination of contracts, purchase orders, and invoices.
    * Support quarterly tax credit exercise: release time allocation surveys, compile and consolidate results, develop review materials and final submission.
    * Obtain and prepare vendor information and proposals for submission to Legal Department for creation of Service Agreements. Set up new vendors when necessary and monitor the database for problems after vendors complete the registration. Ensures that confidentiality agreements and other key contractual elements are in place
    * Maintain understanding of new Procurement/AP/Legal/Finance requirements for vendor and budget management
    * Complete the RND Select process as needed

    20%: Communication
    * Generate slides for various needs of GHEORE leadership
    * Maintain GHEORE Projects SharePoint and manage site access requests,
    * Support compilation of monthly reports
    * Work with internal IT SharePoint team to execute against site and process improvements.
    * New Hire Profiles: Collect profiles from hiring managers, draft communications periodically (quarterly, at minimum)
    * Manage GHEORE departmental Gopher site

    Education and Experience Requirements :
    Bachelor's degree in scientific discipline, or business administration with an understanding of R&D, plus minimum of 5 years of professional experience. Preferred qualifications include experience in biotech/pharmaceutical industry

    Other Job Requirements:
    Occasional domestic may be required

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjAxNDkzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0

    Primary Duties :
    * Implement medical communication plans in designated disease areas [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases]
    * Manage medical aspects of the global Commercial - Medical - Legal - Regulatory (CMLR) materials review process

    Responsibilities:

    60%:
    Implement medical communication plans in [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases]
    * Implementation of the medical communication plan for each disease area, including for example, medical materials (print and virtual), event support and disease state education. Coordinate with other members of the [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases] team to identify and implement medical communications best practices
    * Interact with vendor partners supporting Global Medical Communications in the disease area
    * Support implementation of medical communication platform solutions, including, e.g.
    * Medical congress planning and delivery
    * Medical field force tools
    * Digital / multi-channel approaches
    * External materials review and management *

    40%:
    Manage medical aspects of the global Commercial - Medical - Legal - Regulatory (CMLR) materials review process
    * Conduct day-to-day medical implementation of the Shire CMLR process for promotional materials and review process for non-promotional materials within [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases] . Conduct medical review for one or more disease states / assets
    * Assist other members of the [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases] Global Medical Communication team to ensure CMLR activities are completed efficiently

    Education and Experience Requirements:
    * A relevant healthcare degree is required. A medical or scientific degree (MD, PharmD, PhD, MS or RN) is preferred.
    * >2 years of experience in the biopharmaceutical industry, preferably within a matrix structure
    * >2 years of experience within medical affairs roles (e.g. Medical Science Liaison, Medical Information, Medical Communications, Publications, post doctoral medical communications residency or fellowship)
    * Experience interacting with vendors and managing projects is preferred
    * General knowledge of medical communications approaches and best practices is required
    * Familiarity with regulatory and legal guidelines regarding medical communications strategy and execution

    Other Job Requirements:
    * Availability to travel approximately 20% of time
    * Availability to participate in early or late meetings/teleconferences.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjgxOTUzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0

    Primary Duties :
    * Develop and implement medical communication plans in designated disease areas [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases]
    * Manage medical aspects of the global Commercial - Medical - Legal - Regulatory (MLR) materials review process

    Responsibilities:

    60%:
    Develop and implement medical communication plans in [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases]
    * Collaborate with the Global Medical Team for one or more disease areas / assets to translate medical strategy into medical communication objectives and activities
    * Define and oversee implementation of the medical communication plan for each disease area, including for example, medical materials (print and virtual), event support and disease state education. Coordinate with other members of the [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases] team to identify and implement medical communications best practices
    * Manage vendor partners supporting Global Medical Communications in the disease area
    * Support development and implementation of medical communication platform solutions, including, e.g.
    * Medical congress planning and delivery
    * Medical field force tools
    * Digital / multi-channel approaches
    * External materials review and management *

    40%:
    Manage medical aspects of the global Commercial - Medical - Legal - Regulatory (MLR) materials review process
    * Manage and conduct day-to-day medical implementation and optimization of the Shire CMLR process for promotional materials and review process for non-promotional materials within [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases]. Conduct medical review for one or more disease states / assets
    * Collaborate with other members of the [Neuroscience - ADHD; Neuroscience - Other Indications; GI/IM; Rare Diseases] Global Medical Communication team to ensure CMLR activities are allocated and completed efficiently

    Education and Experience Requirements:
    * A relevant healthcare degree is required. A medical or scientific degree (MD, PharmD, PhD, MS or RN) is preferred.
    * >3 years of experience in the biopharmaceutical industry, preferably within a matrix structure
    * >3 years of experience within medical affairs roles (e.g. Medical Science Liaison, Medical Information, Medical Communications, Medical Education, Publications)
    * Experience managing vendors and projects is preferred
    * Good knowledge of medical communications approaches and best practices is required
    * Familiarity with regulatory and legal guidelines regarding medical communications strategy and execution

    Other Job Requirements:
    * Availability to travel approximately 20% of time
    * Availability to participate in early or late meetings/teleconferences.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjA2MTgzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Org Marketing Statement
    All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

    Role Description
    We seek a highly motivated individual with Ph.D. in systems biology/pharmacology modeling, biochemical engineering or other related field and a demonstrated track record in scientific publication. The postdoctoral fellow will be located in Cambridge (MA), a world-class center of pharmaceutical and biotech research. The individual will build quantitative systems pharmacology model(s) to yield an understanding of how inhibition of Janus Kinase (JAK) pathways correlates with efficacy and safety observations and to inform target selection and clinical trial design. The individual will work in a highly stimulating and multi-disciplinary environment and will have interactions with biologists, precision medicine scientists, clinical pharmacologists, clinicians and systems pharmacology modelers. In addition to building computational models, the individual will also have an opportunity to influence experimental designs towards data generation.

    Responsibilities
    * Create a multi-scale systems model describing inhibition of JAK pathways based on literature data and in-house information
    * Develop linkage between in vitro JAK selectivity and resulting in vivo biomarker responses
    * Apply data mining tools to obtain information on intracellular pathways relevant to inflammatory diseases
    * Identify relevant data (in-vitro, in-vivo preclinical and clinical trial data) for model identification, optimization, and validation
    * Design experiments aimed towards generating data for model validation and testing of relevant hypotheses
    * Effectively communicate model results and outcomes to scientists in non-quantitative disciplines
    * Write scientific publications and present at internal and external scientific meetings

    Qualifications
    * Ph.D. degree in mathematics, engineering or other disciplines related to quantitative pharmacology or equivalent experience with a strong emphasis on biopharmaceutical modeling and simulation.
    * Previous experience in building systems biology/pharmacology models, including ordinary differential equation (ODE) based models is required.

    TECHNICAL SKILLS REQUIREMENTS
    * Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
    * In depth, hands-on knowledge of the state of the art modeling and simulation software and applications in the area of PKPD and systems modeling and simulation (i.e. MatLab, Simbiology toolbox, S-plus, R or comparable applications)
    * Capable of rapidly and efficiently building implementing ODE based models of biological systems, and applying parameter estimation and optimization techniques
    * General familiarity with modeling techniques beyond ODEs, e.g. partial differential equations, Bayesian modeling, population modeling will be a plus
    * Proven track record in scientific communication and writing manuscripts
    * Good understanding of in vivo animal models and drug discovery process is a plus

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=ZWRkeS5uaWNvbGFzLjcwMjM0LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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