Title: Director, Medical Writing              

Reports to:Head of Clinical Operations

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for overseeing and leading the medical writing function and providing strategic input to the planning process when medical writing will be involved in core team processes and creation of key deliverables.  The purpose of this job is to create and to manage medical writing vendor(s), documents and reviews for clinical and regulatory documents (e.g., protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive and experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) and demonstrated experience managing the project work of other outsourced medical writers. 

Roles and Responsibilities

• Work with leads from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.
• Be hands on and also manage the work of other medical writers (mostly through a strategic partner and internal in the future) to prepare documents. This includes training and mentoring in addition to participation in assessing workload and managing work assignments.
• Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
• Ensure a consistent style of presentation of documents to maintain quality and ease of review.
• Lead Team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
• Represent Medical Writing on program teams, IND and NDA Planning teams.
• Ensure SAGE considers utilizing the most up to date medical writing techniques and is well positioned in the planning and preparation of NDA documents.
• Build team of external writers to ensure flexibility and quality deliverables.

Qualifications: 

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action.

• Substantial experience (10+ years) as a medical writer, or equivalent and presenting relevant specialist qualifications (advanced degree preferred).
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment and medical terminology.
• Detailed knowledge of requirements for preparation of key clinical and regulatory documents.
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. 
• Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment
• Demonstrated leadership, problem-solving ability, sense of urgency, ability to prioritize tasks and work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines.
• Experience in resolving conflicting editorial opinions expressed by team members. 
• Experience leading teams/people to prepare clinical and regulatory submission documents.
• Demonstrated experience mentoring and managing the project work of other medical writers.
• Experience working with all levels of management and consulting with key business stakeholders and an ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesse strong written and verbal communication skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of SAGE. 

General Scope and Summary

This is an exciting opportunity to work in a multi-faceted program management role.  Key aspect of the role is to support Discovery and Development Project Leaders with overall program coordination including developing and tracking program timelines and plans and being a focal point of team communications including meeting organization and follow-up.  Interact collaboratively with team members at Sage to ensure alignment on project action items and deliverables.  Facilitate the use of program management tools throughout company.

Roles and Responsibilities

• Assist Program/Product Team Leaders to integrate, document and communicate program plans, track progress and re-forecast as necessary in conjunction with team 
• Manage program timelines, deliverables, metrics and budget
• Organize team meetings including agendas, pre-work, minutes, action items and overall program correspondence
• Assist with execution of project plans within a team environment.  Institute a development pathway with decision stage gates
• Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities.  Ensure detail on investments to be made across the portfolio and $ to complete are well understood and coordinated
• Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies
• Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project
• Develop and implement communication tools that enhance information exchange and stimulate creative project interactions
• Assist Project Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations and other appropriate meetings involving moving through the key decision points of a program

Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in science, business or equivalent - advanced degree preferred
• 3+ years experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry
• Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
• Strong knowledge of MS Office
• Demonstrated ability to work successfully in a matrix environment
• Excellent verbal and written communication, negotiation, team building, presentation, and interpersonal skills
• Established ability to work independently, prioritize and manage multiple tasks simultaneously, and demonstrated ability to identify and resolve issues
• Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player

General Scope and Summary

This is an exciting opportunity to work in a multi-faceted program management role.  Key aspect of the role is to support Discovery and Development Project Leaders with overall program coordination including developing and tracking program timelines and plans and being a focal point of team communications including meeting organization and follow-up.  Interact collaboratively with team members at Sage to ensure alignment on project action items and deliverables.  Facilitate the use of program management tools throughout company.

Roles and Responsibilities

• Assist Program/Product Team Leaders to integrate, document and communicate program plans, track progress and re-forecast as necessary in conjunction with team 
• Manage program timelines, deliverables, metrics and budget
• Organize team meetings including agendas, pre-work, minutes, action items and overall program correspondence
• Assist with execution of project plans within a team environment.  Institute a development pathway with decision stage gates
• Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities.  Ensure detail on investments to be made across the portfolio and $ to complete are well understood and coordinated
• Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies
• Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project
• Develop and implement communication tools that enhance information exchange and stimulate creative project interactions
• Assist Project Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations and other appropriate meetings involving moving through the key decision points of a program

Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in science, business or equivalent - advanced degree preferred
• 3+ years experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry
• Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
• Strong knowledge of MS Office
• Demonstrated ability to work successfully in a matrix environment
• Excellent verbal and written communication, negotiation, team building, presentation, and interpersonal skills
• Established ability to work independently, prioritize and manage multiple tasks simultaneously, and demonstrated ability to identify and resolve issues
• Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player

Title: Senior Director/Director, Development Team Lead, SAGE-689/217                       

Reports to: VP, Portfolio & Program Management

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program executive experience leading early to late stage drug development programs.

Roles and Responsibilities

• Define and articulate clear strategic vision within program teams
• Operational leader for the product development/early development projects and serve as visible program champion and focal point for critical program information
• Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
• Set and maintain focus on overall program objectives and milestones but knowledgeable of supporting detail (tasks, associated expert resources and expense)
• Drive decision point planning and associated deliverables across all functions of the team and contributes to the Sage portfolio planning process on behalf of the program(s)
• Ensure the input from sub-teams to support the advancement of the program’s objectives and deliverables
• Perform full program planning and execution within team environment
• Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
• Propose resource needs for Program
• Develop and own budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.
• Program Status Reporting - ensure program is viable and aligned with corporate strategy
• Accountable for meeting targets and managing deliverables
• Issue Identification and Resolution
• Cross-Functional Coordination and Communication including senior management
• Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

• Advanced degree and 15+ years of multi-disciplinary experience in the biotech/pharmaceutical industry with 8+ years of direct project/program management experience in preclinical and clinical development, ideally honed through a combination of portfolio prioritization, working within a medical affairs organization (or similar) with emphasis on discovery to early development transition
• Demonstrated knowledge of overall drug discovery and drug development processes relevant to pharmaceutical/biotech organizations as evidenced by multiple successful drug discovery program leadership experience
• Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
• Capable of managing multiple programs/brands simultaneously
• Previous experience with portfolio management concepts preferred; must have advanced planning and tracking skills with attention to detail including experience with project management and tools (i.e., MS Project)
• Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
• Be a diplomatic professional, ‘clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors
• Possesses strong written and verbal communication skills
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
• Excitement about the vision and mission of SAGE

Our Translational Clinical Oncology team is seeking a Clinical Trial Leader to join our team in Cambridge MA. 

The person in this role will be Accountable for all aspects of assigned Translational Clinical Oncology (TCO) clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials. 

Major Accountabilities include: 
1. Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol. 
2. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions. 
3. Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s). 
4. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management. 
5. In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations. 
6. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators. 
7. Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems. 
8. Sits on Early Program Team (EPT) to contribute to program strategy. 
9. Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable. 
10. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation with the CRO Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s). 
11. . 
12. For TCO trials led by a US-based clinical trial leader, function as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL be the primary contact for US sites for clinical conduct of the trial. 
13. May participate in the on-boarding and mentoring of new TCO staff. 
14. Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.

Minimum Requirements:

- Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. PhD preferred. 
- Fluent English (oral and written) 
- ≥ 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation. 
- Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process. 
- Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred. 
- Hands-on experience in data cleaning and analysis recommended. 
- Good communication, organization and tracking skills

Apply Directly: https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&siteid=5260&jobid=2398264 

Job Title: New Patient Coordinators Job ID: 27489 Full/Part Time: Full-Time Regular/Temporary: Regular

--------------------------------------------------------------------------------

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.

POSITION SUMMARY:

The New Patient Coordinator (NPC) is often the “first impression” a patient has of DFCI. In this role, you provide administrative support and coordination for aspects of patient care for new patients. This role highlights features of customer service and administrative responsibilities.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Provides administrative support and coordination for all aspects of patient care for new patients.

• Schedules appointments following guidelines that support continuity of care and a high standard of timely communication and rescheduling as necessary.

• Appropriately arranges resources and materials to support the highest standard of patient experience and visit, i.e. review and organize medical records, coordinate receipt of tissue, ensure receipt of new patient appointment packet.

• Answers telephone calls, responds to emails, and manages other referral inputs, as appropriate for new patients. This includes the responsibility to collect detailed clinical information provided by patients, internal/external providers, and others such as staff from ancillary services, and either resolve problems directly or ensure appropriate escalation to management.

• Recognizes emergencies and appropriately respond using standard operating procedures and critical thinking skills.

• Provides program specific information to callers and refer calls as necessary.

• Serves as a liaison for patients including efficient routing of calls per telephone triage guidelines.

• Schedules patient visits, and manages changes, ranging in complexity for one physician appointment to multiple care provider appointments.

• Provides information to the patient regarding the need for insurance referral(s), and refers calls as appropriate.

• Assists in processing paperwork associated with clinical care including: managing materials requests, signing up for EMR portal,

• Collaborates with New Patient Coordinator team to ensure seamless coverage and task management in times of full and partial staffing levels.

• Is able to comprehend and implement new concepts or modifications to processes requests quickly.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Bachelor''s Degree Required

• 2+ years of administrative and/or customer service experience preferred

• Excellent communication, organizational, and customer service skills

• Strong attention to detail

• Must possess the ability to multi-task and problem solve on the spot

• Excellent phone etiquette

• PC proficiency required

• Knowledge of medical terminology is a plus

Schedule

40 hours/ 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

PI92653270

ADDITIONAL REQUIREMENTS

Position Summary

This position supports the Research and Development (R&D) organization and is responsible for assisting in the maintenance, management and retirement of controlled process documents, including the tracking of deviations related to such processes.

Job Responsibilities 

• Ability to navigate and work within an electronic document management system (EDMS).
• Maintain and coordinate activities related to the EDMS including generating, revising and retiring R&D controlled process and operational documents.
• Maintain the metadata associated with the aforementioned R&D controlled documents.
• Ability to handle multiple assignments in a fast-paced environment with changing priorities.
• Process incoming documents according to established document control procedures.
• Maintain process related deviations in accordance with process requirements.
• Prepare and review SOPs to ensure the submitted documents meet R&D controlled document quality standards.
• Assure controlled documents are appropriately reviewed and approved prior to implementation via the change control process. Provide expertise and input to other functional areas related to R&D controlled documents.
• Assist in the generation of metrics and reports related to the R&D process document control.
• Support the periodic review of R&D controlled documents for compliance.
• Assist in the preparation and coordination of requests from regulatory authorities and other compliance inspections/audits.

Experience

• Minimum three (3) years’ experience in a regulated industry
• Knowledgeable in FDA expectations is preferred
• Direct experience in GXP compliant quality systems is preferred

Skills

• Excellent document processing skills including: document quality review, typing and PC skills (MS Word, Excel, PowerPoint, Adobe Acrobat, etc.).
• Excellent communication skills including: customer service, ability to influence, negotiate, and conflict management skills.
• Must work effectively and independently in a team environment and with individuals at all levels within an organization. 
• Additional necessary characteristics include: being a self-starter, goal oriented, attention to detail, and ability to multi-task.

Position title: Research Technician

 Position type: Full-time

Position description: The Research Technician will be responsible for working together as part of a multidisciplinary team and supporting efforts aimed at the over-expression and purification of recombinant human membrane and secretory proteins from the protozoan Tetrahymena thermophila. The ideal candidate is expected to (1) manage lab inventories of reagents, solutions and culture media; (2) maintain lab equipment and glassware in a state of readiness and (3) support experimental work including growth and maintenance of microbial cultures and analysis of recombinant DNA and protein.

Position requirements:

• BS or MS in Molecular Biology or a related field.
• Knowledge of recombinant DNA techniques including PCR, DNA/RNA purification, plasmid cloning, screening for expressed gene products by Western blotting and microbial culturing techniques would be highly desirable.
• Experience in the biopharmaceutical industry would be a benefit.

The candidate is expected to be primarily self-directed and to be highly motivated to drive the above activities. She/he should possess excellent verbal and written communication skills, as well as good organizational skills.

 About the company: Tetragenetics, Inc. is an early-stage biotechnology company meeting the needs of drug discovery via an innovative platform technology for the production of genetically engineered proteins. We accomplish this by harnessing the unique biology of Tetrahymena thermophila.

This position is located at the company’s facilities in Arlington, MA. Tetragenetics is an Equal Opportunity Employer.

 Contact information:

Please send resume and cover letter to:

careers@tetragenetics.com

Position Description:

Reporting to the Associate Director of QA Operations, the QA Specialist is responsible for assisting the Quality teams with the administration and processing of GMP documentation and all associated tasks.  The QA Specialist provides appropriate support in all department initiated continuous improvement projects and aids the team to ensure compliance to applicable regulations and standards as needed. The Quality Specialist is required to possess strong computer skills and a high-level of written and verbal interactive communication skills.

Responsibilities:

• Provide assistance in ensuring that departmental records, Quality Management System procedures, specifications, SOP’s etc…comply with FDA Quality Systems Regulations
• Maintain documentation for Quality Systems by organizing, filing, retrieving, cGMP documents and electronic records in Ironwood’s Document Storage Room (IPARC)
• Archive and ship documents to Ironwood’s off-site storage facility (Iron Mountain)
• Provide administrative / technical support to Quality Operations and Quality Systems teams with data entry into QA databases, spreadsheets and generating power point presentations.
• Support Documentation Management and QA Operations Leads by routing documents and assisting with follow-up.
• Assist in the review, tracking, trending and generation of excel based metrics and trending tools as directed by QA Leads
• Triage and prioritize cGMP documentation such as deviations, investigations, change controls internally and from contract manufacturers.
• Perform QA documentation review and facilitate approval of test methods, batch records, stability protocols, method validation protocols and reports and audit reports.
•  

Position Requirements:

• A Bachelor’s Degree in a scientific discipline or equivalent
• 3 - 5 years pharmaceutical industry experience within Quality Assurance with working knowledge of FDA
• working knowledge of cGMPs
• Resourceful, self-starter and team player with a sense of urgency
• Strong organizational, planning, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
• Strong verbal and written communication skills
• Excellent interpersonal skills
• Ability to remain focused with regards to details
• Ability to work in a fast paced, ever changing corporate environment
• Ability to read, analyze, and interpret technical procedures and regulations.
• Ability to write reports and SOP’s.
• Ability to effectively present information and respond to questions from groups
• Must be able to work under minimum supervision and in a team environment
• Knowledge of word processing, spreadsheets, and applicable database applications
• Highly proficient in using MS Excel & Word

Are you an experienced and creative research associate with biotech/pharmaceutical experience that is seeking a role that will value your technical and mental contributions? Are you tired of being treated as the standard "pair of hands"? If so you need to take notice of our clients opportunity to add an experienced Principal Research Associate to their growing Biology team. They want a valuable contributor to help advance their pipeline studies that can think collaboratively and work with little hand holding. Required and Desired Skills: Ability to think and contribute scientifically in group setting to add value to the organization. Success in prioritizing work for targeting, identifying, and validation of oncology therapies. Experience and expertise with oncology cell lines. Hands on experience with ChIP Seq, genetic screening (siRNA, shRNA, CRISPRs), and novel and phenotypic assay development. MS 5-10 years of industry experience. BS 10+ years of industry experience.

About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Clinical Assay Supervisor (Needham, MA)

Overview:

This position will manage direct reports in clinical sample analysis in the Needham GLP lab.  Duties include delegating work assignments, performance management and talent development.

Position Responsibilities:  

Supervisor/Manager role:

• Supervise technical staff.
• Plan and direct projects.
• Lead and inspire team. 
• Author and approve technical documents, such as protocols, methods, procedures and reports

Management of Clinical Trial Sample Receipt and Analysis:

• Develop and execute laboratory work plans/schedules for team
• Ensure GLP compliance, coordinate with Quality Assurance group on audits and audit responses of sample receipt, in-phase audits and data transfer audits, and on the maintenance of the Master Schedule
• Manage multiple projects, with responsibility for project outcome and interaction with Celldex Clinical team
• Review raw data for accuracy, completeness, data integrity and compliance with protocols and standards
• Identify and independently drive department level enhancements.

Education/Experience:

• Experience must include technical and management roles in the biotechnology or pharmaceutical industry supporting the development and/or commercialization of therapeutic recombinant proteins.
• Must have scientific and management/leadership experience in a lab setting dedicated to the bioanalysis of clinical samples.
• Must have practical experience working with sample receipt and accessioning (experience with LIMS a plus).
• Knowledge of immunoassay methods (ELISA, etc) and their applications in characterizing therapeutic proteins with respect to, for example, pharmacokinetics and immunogenicity
• Statistical data analysis experience is required (SoftMax Pro, GraphPad Prism)
• Supervisory experience of 2+ personnel is required 
• Strong verbal and written communication skills
• BS/MS/PhD in biological sciences with 6+ years relevant experience  

Primary Duties
Provides regulatory support and guidance in the review and approval of impactful and compliant advertising and promotional communication, disease state education and field training materials. Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription pharmaceutical products. Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial organizations. Establishes and maintains favorable interactions with FDA.

Responsibilities
40%
Provides regulatory evaluation of all draft promotional materials for assigned brands. Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies and business objectives. Conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling. Works collaboratively with Medical, Legal, and Commercial colleagues to achieve alignment. Interprets the adequacy of presented scientific data to support promotional claims. Provides consistent, well-supported, and clear guidance.

10%
Serves as primary liaison with FDA's OPDP and/or APLB reviewers in the request and negotiation of Advisory Comments and any other interactions regarding promotional use of claims for assigned products.

30%
Maintains a thorough understanding of OPDP and APLB requirements as well as a keen awareness of enforcement trends. Participates in the preparation and review of comments to FDA's docket regarding Federal Register Notices that may impact the organization's promotion of commercial products.

20%
Collaborates with the International Advertising and Promotion review teams for materials that are intended for global audiences.

Education and Experience Requirements
* BA/BS, advanced degree preferred.
* 5 years of Regulatory Affairs experience in the pharmaceutical/biotechnology industry.
* Candidates with experience in related fields may also be considered.
* Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical products.
* 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=amRpZXR6LjkwMDMyLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role
The Regulatory Training Manager will develop, deliver, update and maintain training materials for classroom-based training as well as e-learning at a global level. The Regulatory Training Manager will participate in initiatives to develop e-learning to support GRA and other impacted functions (within and outside of R&D). The Regulatory Training Manager will ensure that all training materials are compliant with existing Shire Policies, SOPs and processes.

Responsibilities:
40%

Drives the implementation and direction of GRA's training program and solutions:
* Contribute to developing/maintaining the Regulatory Affairs training materials as part of the Global Regulatory Affairs training program.
* Responsible for analyzing, designing and revising current GRA training curriculum.
* Responsible for developing and issuing communications for training within and outside of GRA.
* Responsible for coordinating decisions impacting training with members outside of GRA and taking initiative to ensure appropriate discussions are taking place.
* Responsible for identifying/implementing appropriate tools and technology to implement training (e-learning), ensuring GRA remains up-to-date with industry standards.
* Responsible for analyzing existing training materials to facilitate achievement of business objectives.

35%
Delivers training solutions:
* Responsible for developing and maintaining global training materials (classroom-based and e-learning).
* Responsible for managing training vendors globally.
* Responsible for scheduling, coordinating and delivering training (classroom-based and e-learning) globally.
* Responsible for training all individuals globally within and outside of R&D on GRA-led initiatives and training courses.
* Responsible for ensuring training records of personnel attending GRA-led training are appropriately maintained.

15%
Lead and contribute to GRA "special projects" for the continuous improvement of GRA:
* Participate in and/or provide project management support for GRA special initiatives, including the development of project scope, metrics, success measures and reporting of overall outcome.
* Create and deliver presentations that support the Process, Standards and Training group.

10%
* Management of vendor resources, when applicable.
* Delegation of tasks in a matrix environment, providing feedback to staff and their line management.

Education & Experience Requirements:
* Bachelor's degree in scientific field is required.
* 5-8 years of pharmaceutical experience in an R&D environment.
* Generally has at least 1 year of experience in electronic document management technology
* Experience with elearning platforms and technologies strongly preferred
* Experience in drug development and knowledge of regulatory submission content and formats preferred.

Other Job Requirements
* Domestic and international travel may be required for this position.
* Approximately 5% travel is 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=amRpZXR6Ljc5ODcwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role:
The Regional Business Manager (RBM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RBM will develop strong working relationships with all physicians within their geographic responsibility who treat patients appropriate for the Shire Rare Disease portfolio of LSD products. This entails the promotion of the drug for Gaucher Type 1 Disease and for Hunters Syndrome (MPS II) within approved labeling, to all targeted physicians and patient candidates. The RBM's primary objective is to identify providers managing patients and educate those providers regarding the benefits of using our therapies with appropriate patients. Further, once an appropriate patient is identified by the provider, assist the clinical staff with the steps necessary to get the patient on drug. This may include areas such as reimbursement, proper testing, and site of care determination.

Responsibilities:
This position will be responsible for all business related activities within their geographic responsibility, including achievement of sales goals, business planning, and expense control. The RBMs will call on Physicians and affiliated staff responsible for the care of patients.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required.
* Minimum of 8 or more years applicable selling experience, preferably in Biologics
* Candidates must demonstrate a consistent track record of success (Top 20% performance).
* President's Club or other top tier awards preferred.
* Biotech, biologics, and specialty pharmacy experience helpful
* Complex sales model experience is a requirement.
* Rare disease experience is a plus.
* Must be able to demonstrate strategic territory management successes

Demonstrates proficiency in the following key Shire Competencies:
- Builds and Leverages Relationships
- Demonstrates Business Acumen
- Drives Results and Execution
- Supports Our Regulatory Environment

Key Skills, Abilities, and Competencies:
* Excellent questioning and probing ability in a sales call
* Technical competence-Excel/CRM/Data analysis
* Large and small group presentations
* Relationship management
* Teamwork and collaboration
* Adaptability in a fluid market place and growing organization
* Ability to work independently

Other Job Requirements:
* Candidate must live in territory
* Must work evenings and weekends as needed
* Extensive travel required and varies by territory
* Candidates must possess a powerful sense of urgency, a strong desire for results and a strong work ethic.
* Territory includes Colorado and West Texas

About Shire:
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=bHZhaWwuNDkzMzEuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Role:
*Providing leadership and management within CD to provide medical and scientific support for products within assigned therapy area.
* Support development and execution of medical & clinical strategy for assigned Shire product(s).
* Oversight of study design and data generated, including clinical trial medical monitoring, from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
* Provide primary medical leadership in execution of clinical trials
* Partner with other Shire functions to communicate scientifically accurate information to external stakeholders, meeting appropriate legal and regulatory requirements.
* Acting as a senior company representative interacting with external scientific leaders and/or Regulatory authorities.
* Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
* Co-chair of the safety review team for assigned products
* This position may be combined with the GCDL position when the program is limited in its scope and complexity

Education & Experience Requirements:
* M.D. degree (required); specialty training in rare diseases (preferred)
* Experience working in rare diseases is highly preferred
* Generally has at least eight (8) years of experience in the Pharmaceutical Industry with relevant industry experience.
* Demonstrated ability to collaborate in a matrixed environment
* Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
* Experience in designing and conducting Phase II-III clinical trials; and/or
* Significant late-stage development research.

Other Job Requirements:
* Availability to travel approximately 25% 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=YXN0YW5pdHMuOTAzNTYuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Role:
Primary responsibility is to oversee the quality and compliance of Individual Case Safety Reports (ICSRs) entered into the Shire Global Safety System (SGSS) and ensure systematic documentation of adverse event (AE) data in the SGSS has been entered in accordance with standard operating procedures (SOPs). The incumbent is responsible for Shire's 3rd party case-processing vendor(s) as it relates to quality and compliance of end-to-end case processing activities. Leads initiatives to identify and implement enhancements to improve quality, compliance, productivity and efficiency as case processing activities. Responsible to train and mentor PVRM staff on the use of SGSS to ensure consistency and compliance.

Responsibilities:
40%:
* Review 3rd party vendor's case processing quality, coding, seriousness / listedness / causality assessments, narrative writing, and overall consistency and provide quality improvement feedback
* Monitor 3rd party vendor's timeliness to ensure compliance to company and global regulatory reporting requirements
* Serve as the PVRM single-point of contact for vendor's day-to-day activities and urgently address and/or escalate any issues

35%:
* Ensure the standardization, quality and consistency of ICSRs to support signal detection activities and aggregate report analysis.
* Identify and lead efforts to enhance quality, compliance, productivity and efficiency of case processing activities

10%:
* Support AE case processing training and mentoring of PVRM staff, including contractors, to ensure AE data is consistent, standardized and of high quality

10%:
* Management responsibilities include, but are not limited to, oversight of daily activities, goal setting and performance appraisals of direct reports

5%:
* Serve as subject matter expert for the development of SOPs relating to case processing to ensure consistency, standardization, and compliance to good Pharmacovigilance practices

Education & Experience Requirements:
* Bachelor's degree in a science or healthcare related field or a Registered Nurse or other clinical degree is required.
* At least 5 years of drug safety experience in a pharmaceutical company with demonstrable skills in AE case processing activities, including data entry, MedDRA coding, narrative writing, and assessment of reportability
* Post-graduate qualifications and previous line management experience is desirable.

Other Job Requirements:
Domestic and international travel will be required (

May be required to travel domestically and internationally to other Shire sites and CROs to provide training or to external meetings. Driver's license optional but preferred.

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=c3N6Y3plc255LjI0OTQ0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

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 qualified candidate will join the Analytical R&D organization, which enables development of biological therapeutics in Pfizer Research and Development. Within Analytical R&D the candidate will join the Project Progression & Biochemistry Group. This group develops analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline; this includes method development, process support, formulation and stability support, product characterization and method qualification. The technical associate will provide essential laboratory management support for the department, enabling scientific staff to focus on method development and product characterization.

Responsibilities
The candidate will have multiple responsibilities. In particular, the candidate is expected to coordinate sample pick-up, maintain sample inventory and facilitate sample shipping. In addition, the candidate will be responsible for capital procurement. This includes being the single point of contact for coordinating capital equipment purchase and installation. The candidate will also be responsible for general laboratory management including laboratory housekeeping, ensuring that workstations and common supplies are appropriately stocked, and management of basic analytical equipment maintenance. The candidate will ultimately be expected to become proficient in running routine analytical methodologies including protein purification, appearance and pH. The candidate must excel at working in a collaborative, fast-paced environment and must be comfortable with shifting priorities and last minute requests.

Qualifications
MINIMUM: The candidate should have 1 year of experience working in a scientific laboratory or manufacturing environment. Candidate must have good interpersonal and collaborative skills, excellent communication skills (verbal and written), and experience functioning in a team environment.

DESIRED: Other desirable attributes are:
* Detail oriented with strong organizational skills
* Excellent documentation skills
* Excellent communication skills (written and verbal)
* Experience with Microsoft Excel, Word, and Powerpoint

PHYSICAL/MENTAL REQUIREMENTS
Position requires occasional light lifting and periods of standing, sitting or walking.

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=SmFtZXMuQ3JvbmluLjc3MzcwLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

Senior Scientist/Study Manager-DMPK

There is an opportunity for an experienced scientist to join our DMPK team based in Watertown, MA.  The successful candidate will be responsible for managing and conducting ADME studies.  The role will also involve writing reports and QC’ing of data/reports. 

Experience and knowledge

• MS or PhD trained with 3-5 years industry experience in the field of in vitro DMPK.
• Ability to work in a fast-paced, team environment with a good appreciation of deadlines and customer service.
• Excellent written and verbal communication skills.
• The ability to make decisions, troubleshoot and work independently.

 Principal Accountabilities

 To manage and oversee DMPK projects/studies and client studies ensuring all work is performed to a high standard within expected timelines

• To manage client studies ensuring all information is communicated effectively to laboratory staff, client requirements are followed and data is returned within specified deadlines and provide expert advice and data interpretation
• Participate in experimental design, conducting experiments, reviewing data, and writing reports
• To assist the QC manager in reviewing data and reports.
• To assist other Laboratory Scientists in troubleshooting
• To co-ordinate with the other Laboratory Scientists to ensure appropriate protocols and study designs are being followed
• Assist business development in the preparation of protocols and contracts for new customers.

Skills and Competencies

• Hands-on experience and in-depth understanding of in vitro DMPK assays (e.g. metabolic stability assays (microsomes, hepatocytes, plasma, etc.), enzyme kinetics, CYP inhibition, CYP induction, permeability, solubility, protein binding, and other typical early and late-stage DMPK assays).
• Practical experience in LC-MS/MS analysis of small molecules and peptides
• Ability to troubleshoot and find solutions to problems
• Communicates proactively and regularly
• Ability to effectively multi-task
• Prior experience working in a CRO is a plus

 To apply, email your résumé to US-careers@cyprotex.com

This position is accountable for supporting the day-to-day compliance program for employees in Takeda’s Chief Medical & Scientific Officer (CMSO) organization based in the US.  Along with R&D Compliance colleagues, he/she is responsible for embedding the elements of an effective compliance program throughout the US R&D organization, including Takeda Development Centers-US, and US-based employees in Pharmaceutical Development Division (PDD), Global Medical Affairs (GMA), Oncology Business Unit, New Frontier Science, and Therapeutic Area Units (TAU). 

ACCOUNTABILITIES: 

• Responsible for providing strategic input into Global Compliance Policies and SOPs that affect  US-based CMSO employees.
• Anticipates changing industry regulatory climate and assists in proactively aligning function goals and processes with current regulatory expectations.  Interacts regularly with industry peers, Takeda Legal and Regulatory personnel and vendors to help shape direction of the R&D compliance program. 
• Responsible for providing guidance to all US-based CMSO personnel who contact the Global Compliance Hotline.
• Provides compliance support for alliance partnerships for R&D organizations from a compliance perspective.  These partnerships include co-licensing and joint venture agreements.  Responsibility for working in conjunction with his/her counterparts in these organizations to ensure compliance with state and federal health care program requirements.
• Responsible for leading and understanding evolving risks throughout the pharmaceutical pipeline cycle and ensuring adequate controls in place to mitigate those risks.
• Actively participate in and potentially manage day-to-day compliance monitoring initiatives to ensure compliance with Takeda policies involving advisory boards, Investigator Initiated Sponsored Research (IISR), Takeda-conducted clinical trials, Investigator meetings, Sponsorships, Consulting and other fee for service arrangements, and other business activities that involve HCPs within the CMSO organization.
• Responsible for assisting in the coordination of R&D Compliance Committee meetings.

Qualifications

EDUCATION, EXPERIENCE AND SKILLS

  Required:

• Bachelor’s Degree
• 10 years of experience in healthcare industry, a portion of which involves R&D
• Excellent communication skills
• Proficient in Microsoft Office products
• Solid understanding of state and federal health care laws/regulations
• Demonstrated project and program management skills. Experience in leading cross-functional projects and initiatives.
• Strong customer relationship skills and ability to interact with all levels of management, vendors and partners.
• Proactive, self-motivated, and able to work well in dynamic environment while consistently exercising good judgment.
• Able to work and deliver on deadlines while managing multiple projects and priorities effectively

Preferred:

• Pharmaceutical compliance experience with 5 years in an R&D compliance related role

We are driven to improve people's lives.  

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx