Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

ImmunoGen, Inc. is in search of a highly motivated individual to join the Antibody Engineering group. He/she will contribute to the Discovery projects portfolio by supporting the efforts to humanize and optimize lead antibody candidates while helping to drive the new technology platform. This RA I/II will be primarily responsible for performing gene design, cloning, and expression in both mammalian and prokaryotic cells. Other activities will include antibody/protein biochemical characterization and binding analysis using ELISA and Biacore/Octet.

Who You Are

The qualified candidate will possess a BS in biology or related discipline and have 1- 3 years of extensive hands on laboratory experience with:

• Standard molecular biology techniques
• Mammalian tissue culture
• A familiarity with DNA/protein sequence analysis and editing software
• Experience with ELISA, Biacore/Octet
• High throughput antibody screening techniques
• The ideal candidate should also have strong organizational skills and demonstrated ability to handle multiple tasks and work in a team environment.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

The Provantage Laboratory Services Group seeks a self-motivated Project Coordinator to coordinate validation testing on Biopharmaceutical/Pharmaceutical formulations of customer products and solutions. Candidate is responsible for being the technical liaison for laboratory scale validation studies performed by the Provantage Laboratory Services Group.

The Validation Project Coordinator (VPC) is the "Study Director" responsible for the design, conduct, and reporting of the study results to the external Biopharmaceutical/Pharmaceutical customer. The VPC is responsible for project planning, timeline management, customer communication, as well as technical consultancy and guidance to adapt service scope to specific customer needs. As well as those listed above, the VPC is responsible for project logistics such as sample reception, protocols and reports communication, and the overall coordination of validation studies for EMD Millipore global customers. The role of the position is to support EMD Millipore products in customer applications and to supply technical resource for the validation aspect of customer filtration processes.

Job Requirements:

• Bachelor’s degree in biology or related science discipline with a 2-5 years of experience or a Master's degree with a 1-2 years of experience from Biotech/Biopharmaceutical industry
• Must be able to work in a fast paced environment
• Must be organized, neat, have good documentation skills and practices, and good project management skills
• Excellent written and verbal communication skills and presentation skills
• Excellent communication skills and the ability to work in team environment and possess the ability and skills to interface with various departments and customers
• Ability to work with customers
• Prior experience of QA/QC, validation and/or similar laboratory experience
• Aptitude for initiating testing procedures and protocols and/or development of new methods
• The ability to plan laboratory testing, solve problems, develop reasoning related to test results
• Strong aptitude in laboratory skills with the ability to multitask and handle different projects/responsibilities simultaneously
• Good record keeping abilities and computer/data skills

Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.

The Pharmacovigilance and Risk Management (PVRM) team at Merrimack is an emerging consolidated function having been launched in Q3 2014. PVRM is tasked to provide pharmacovigilance/patient safety and risk management expertise in all phases of development for all compounds in Merrimack’s portfolio from first in man to post-approval.  

We are seeking a talented Pharmacovigilance and Risk Management Scientist to join the growing PVRM team. This position will be responsible for establishing and delivering post-approval pharmacovigilance expertise, participating in cross-functional clinical trials teams, performing CRO PV oversight, and assuring PV global compliance (e.g. 100% on-time submission). This key position reports directly to the Head of Pharmacovigilance and Risk Management.

Job Responsibilities:

• Provide Pharmacovigilance guidance, as needed to clinical and post-marketing cross functional teams
• Increase collaboration with clinical and post-marketing teams and communication of safety concerns
• Develop and maintain a vendor management/oversight plan
• Provide complete PVRM product life-cycle support for assigned product(s)
• Participate in the development of protocols, annual updates to the compound-specific Investigator’s Brochure (IB), contribute and review Informed Consent Forms (ICF), ensure safety oversight in cooperation/leadership of the clinical trial medical team, represent PVRM in SAE reconciliation, final CSR narrative writing/review and contribute to the review of the final clinical safety report (CSR).
• Perform any study-start activities, as necessary.
• PVRM Liaison with Merrimack call center, Merrimack quality, and Merrimack Medical Information/Affairs, Sales and Marketing.
• Acts as primary author for assigned product aggregate periodic reports such as the DSUR and PSUR.
• Perform on-going individual case quality review of representing company review in accordance with study Safety Management Plans, PV Agreements and Merrimack SOPs
• Identify Data Entry errors and document these errors as feedback to CRO(s)
• Effectively communicate with CRO on findings
• Identify case management processes that are inconsistent or not well defined and communicate this to the PVRM team/supervisor
• Provide input to PVRM team/supervisor on suggested improvements in case management processes
• Support the PVRM team/supervisor as needed in producing aggregate c PVRM reports for medical management team review.
• Monitor and communicate with Merrimack clinical team regarding cases that have exceeded the internal case flow timelines.
• Support PVRM team/supervisor in identifying areas of concern regarding case flow timelines.
• Work within a team environment
• Be familiar with global regulatory requirements for clinical safety data processing into individual case reports and related Merrimack procedures.
• Liaise with other Merrimack functions and participate in staff training, as needed
• Develop expertise in assigned products and therapeutic area
• Respond or coordinate response to standard and ad hoc safety queries.
• Alert appropriate management as soon as a potential signal or trend is recognized.
• Assist in developing and implementing PVRM standard processes and procedures
• Serve as a compliance role model that is consistent with the mission, vision and values of the organization. 
• Other items, as needed

Requirements:

• Bachelor’s degree (or equivalent) in health-care related field (strongly preferred) with Oncology experience preferred
• Minimum of three years industry experience with concentration in clinical safety highly desirable and/or advanced degree in related field.
• Minimum of five years post-marketing PVRM experience
• Minimally a basic working understanding of drug/device safety filing procedures as well as competent knowledge of domestic and international regulatory requirements highly desirable.
• Excellent writing and verbal communication skills.
• Must be experienced with standard word processing, spreadsheet, and safety data base packages.
• Proven ability to critically think through complex medical/safety reports and effectively summarize key information in a concise narrative presentation
• Experience in vendor management preferred
• Excellent oral and written communication skills
• Flexible, highly organized with the ability to prioritize and detail oriented
• Self-motivated with the ability to function well in a cross functional team
• Strong interpersonal skills
• Ability to manage multiple projects simultaneously and complete those projects on time while effectively demonstrating the ability to influence others and accomplish goals within a team environment
• Strong commitment to business ethics
• Passion for fighting cancer

If you are interested in a great opportunity at a fantastic company, please click the link to apply:

https://app.jobvite.com/j?cj=oCAD1fwA&s=Mass_Biotech_Council

https://home.eease.adp.com/recruit/?id=14960371

https://home.eease.adp.com/recruit/?id=14960371

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

ImmunoGen is seeking an experienced individual to join the Cell Culture Development team and play a key role in establishing and optimizing highly productive CHO cell culture media and feeds for recombinant antibody manufacturing for ADCs.  Reporting to the Associate Director of Cell Culture Development, this individual will provide technical and scientific expertise in the design and execution of cell culture experiments to enhance productivity, product quality, and process robustness.  This Scientist II / Senior Research Associate will maintain close communication with the Cell Line Development group and supporting functions to ensure development of medium formulations which meet evolving cellular and product quality demands.  The successful applicant will apply principles of QBD, DOE, and statistical analysis to build process knowledge.  This individual will stay current with relevant industry trends, technologies, and regulations.

Responsibilities

• Provide technical expertise and leadership in planning, designing, and executing cell culture experiments with a focus on media and feed development.
• Perform data analysis and communicate results for development and optimization of upstream bioreactor processes which are safe, robust, and repeatable.
• Develop and optimize highly productive media and feed formulations which balance platform approaches with project demands for cell lines, clones, and processes.
• Establish and optimize small scale experimental platforms, workflows, and equipment.
• Apply QBD principles to establish product and process knowledge.
• Maintain close communication with the Cell Line Development group and supporting functions to ensure development of formulations which meet evolving cellular, product, and process requirements.
• Responsible for high quality of documentation, protocols, development reports, tech transfer reports, sections of regulatory filings, etc.
• Represent ImmunoGen and Cell Culture Development in project team meetings, scientific forums, and with CMOs and strategic partners.
• Stay current with industry standards, new trends, technologies and technical developments and all applicable regulations.

Who You Are

• Level is flexible for a Senior Research Associate up to Scientist II.  Cell culture medium and feed development experience is highly desirable.
• Degree in Life Sciences, Chemical or Biochemical Engineering or related discipline.  Ph.D. with 2+ years, MS with 4+ years or BS with 6+ years of industry experience related to cell culture media, feed, and bioreactor process development in support of cGMP manufacturing.
• Deep understanding of DOE, statistical methods, QBD, process, and analytical development activities for CHO cell culture media and feed development.
• A strong scientific approach to solving problems and a proven track record of accomplishment in the design, development and implementation of bioreactor cell culture processes.
• Experience working with high throughput microreactors, benchtop, and single-use bioreactors, is highly desirable.
• Enthusiastic, team player with passion for growth and innovation.  Excellent oral and written communication skills.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc.,  ImmunoGen, Inc. shall not owe any fee to the submitting agency.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

ImmunoGen, Inc. is searching for a talented and motivated Senior Scientist to join the Pharmacology group.  The successful candidate will play a key role in the evaluation of novel antibody-based therapeutics, and the position offers the opportunity to interact with other groups across the entire Research and Development organization.  The candidate is expected to contribute to building a culture that embraces scientific excellence, urgency, partnerships with key stakeholders, and continuous learning and improvement.

Who You Are

• The qualified candidate will hold a PhD in Pharmacology or related discipline and 8+ years of experience in the pharmaceutical/biotechnology industry.
• Excellent in vivo skills with syngeneic/xenograft tumor models
• Strong experimental design and data analysis skills
• Previous supervisory experience is essential
• Ability to successfully coordinate and deliver through both internal resources and CROs
• Excellent written and oral communication skills for both verbal presentations and generation of documents to support internal interactions, external partners and regulatory bodies, and the ability to work in a team environment are required
• Experience with PK/PD modeling would be desirable.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Director Antibody Development will be responsible for managing the upstream and downstream antibody development groups in support of ImmunoGen’s Antibody Drug Conjugates (ADCs). This individual will also establish a Process Engineering team in support of technology transfer, process management at CMOs, process validation.  The Director Antibody Development will report to the VP, Process and Analytical Development (PAD), and will be a member of the PAD senior staff and as such, will jointly exercise responsibility for the development and implementation of the company’s corporate Technical Operations & Manufacturing strategy and plans.  He or she will also ensure strong alignment and coordination with other functions within PAD and Technical Operations including cell line development, conjugation development, drug product development, process chemistry, analytical and bioanalytical sciences, manufacturing sciences, manufacturing and quality. The Director will also be expected to sustain and extend the high level of scientific and engineering rigor within PAD.

Responsibilities to include:

• Manage and develop the cell culture and purification teams whose primary responsibility is to design and develop manufacturing processes for antibody components of ImmunoGen’s ADCs
• Development of a highly productive process platform including alignment with cell line technology, media and culture process optimization and efficient harvest and downstream operations
• Develop late stage development and process characterization capabilities
• Establish a Process Engineering team in support of late stage development, CMO management and validation
• Ensure that the scientific and technical capabilities of these groups are state of the art and stay current
• Stay current with industry standards, trends, technologies and technical developments and all applicable regulations
• Provide technical leadership in process-related investigations
• Serve a subject matter expert in supporting GMP manufacturing as well as exploring manufacturing options for ImmunoGen internally or externally
• Support regulatory filings
• People leadership and career development, building a culture of Safety and Quality and continuous improvement
• Assists in budget planning and execution
• Represent ImmunoGen in scientific forums and through publications

 
Who You Are

• PhD in Chemical Engineering, with at least 8+ years of relevant industry experience in biopharmaceutical drug development  and subject matter expert in upstream or downstream processing
• Deep experience in process engineering and scale up, scale-down modeling, and troubleshooting of large scale manufacturing equipment used for mammalian cell based production processes
• Experience in late stage process optimization and process characterization for antibody products
• Process Validation experience including validation protocols, reports and hands on experience
• Demonstrated ability to manage scientifically and operationally complex programs
• Demonstrated publication history
• Excellent people skills and track record of success building relationships and working cross functionally

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

ImmunoGen is seeking a dynamic and motivated professional who will join the Process Chemistry team and play a key role in developing analytical methods for the characterization and optimization of routes to ImmunoGen’s small molecule linkers and payloads.   The Analytical Chemist will oversee custom manufacturing operations (CMOs) in their development and optimization of these methods as well as insure they are phase ready.

Job Responsibilities include, but not limited to the following:

• Design and oversee the development of robust analytical methods to characterize small molecule processes.
• Analyze, interpret, and present experimental data to communicate results and continuously improve analytical methods for performance and understanding.
• Responsible for high quality of documentation development reports, tech transfer reports, Batch analyses, etc.
• Interact with colleagues from ImmunoGen’s Process Chemistry group, as well as Process Science and Engineering, Analytical and Pharmaceutical Sciences, Quality, and Manufacturing to support the development of small molecule  processes that are safe, efficient to operate and compliant.
• Stay current with industry standards and trends.  Evaluate new technologies, procedures, and technical developments.

Who You Are

• Degree in Analytical Chemistry or related discipline.  Ph.D. with 8 years of industry experience related to method development and analytical characterization of small molecules  in process development and cGMP manufacturing.

Required:

• Thorough knowledge of analytical chemistry with and understanding of organic chemistry
• Enthusiastic, team player with passion for growth and innovation.
• Excellent oral and written communication skills
• Demonstrated technical proficiency and creativity, with proven ability to independently design and execute experiments
• Excellent organizational and time management skills
• Travel nationally and internationally when needed

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Mission Statement

Symbiota is pioneering microbial solutions for Agriculture. By unlocking the beneficial microbes that naturally live within healthy plants, Symbiota is developing breakthrough products that harmoniously work with plants to naturally promote crop health and performance.  Symbiota has built the first platform for microbiome product discovery in globally important crops, including corn, soy, wheat, cotton, and vegetables. Product Development plays a cornerstone role in advancement of outcomes from our discovery program towards commercialization and enhancing our understanding of performance interactions and drivers.

Symbiota is currently expanding its field trialing and product development capabilities to support development and advancement of our product leads and to enable the development of data/knowledge assets that enable optimization of our efforts spanning discovery, development, commercialization and product use.

Role Purpose: The purpose of the Director of Field Trialing is to lead the planning and implementation of Symbiota field trialing efforts in support of agreed business needs and priorities.  Measures of success include the efficiency of trialing planning/operations, quality of trial outcomes, compliance with policies/regulations and the recruitment, management and development of internal and external team members.

Outcomes

• Symbiota has a fully developed and functioning network of field trial cooperators who deliver high quality field trial results the meet our business needs (on time, on budget, high quality, target environment, well annotated environment/trials, etc.) 
• Field trial planning and implementation process enables the timely and effective engagement of resources and the monitoring of progress at appropriate milestones for effective trial completion (space planning, entry nomination, trial design, protocol definition/communication, materials planning, cooperator contracting, cooperator training, trial/cooperator monitoring, data collection and analysis). 
• In field observations linked to well conducted, annotated and analyzed trials lead to insightful and actionable results presented in a way that which enables Symbiota business decisions relative to advancement, placement, management and development of our microbial products. 
• Continual evolution of field trialing methodologies in service of improved quality, efficiency and knowledge content from our trialing efforts. 
• A motivated, capable and high quality staff and contractor network capable of reliable delivery of field trial outcomes. 
• The creation of a “data asset” that supports current trial objectives and establishes a high value data resource that creates optimal value for broader needs spanning discovery, development and commercialization needs.

Responsibilities for the Director of Field Trialing

• Design and oversee ongoing implementation of the Symbiota field trialing efforts that support the business needs/objectives.  Provide innovative and creative field validation solutions to confirm plant-microbe interactions. 

• Establish field trialing support infrastructure capable of overseeing and optimizing the results from Symbiota field trialing effort 

• Recruit, hire, train and manage 3-5 direct reports and additional seasonal staff 

• Establish and maintain a field trialing network consisting of collaborators and contract service providers capable of delivering on Symbiota field trial needs 

• Continuous improvement of direct reports and contractors through performance management, training, mentoring and development initiatives 

• Drive the implementation of trial meta-data collection and environmental characterization to optimize biological insight and long term value of trial data and observations 

• Work with Symbiota colleagues to plan and track trial demands and facilitate timely and effective trial planning and design 

• Ensure that field trial plans align with needs for effective stage gate advancement of candidates in the product pipeline 

• Define and communicate trialing protocols and standards to Symbiota trialing cooperators 

• Design and implement trial cooperator training and milestone tracking process 

• Ensure timely data collection, data quality control/release and the routine analysis of trials 

• Contribute to and/or lead in depth analysis and interpretation of field trial results 

• Operation of an efficient and reliable trialing platform that meets our evolving field trial needs. 

• A reliable, efficient and predictable field trial process that spans trial planning, trial implementation, data collection, data quality control and routine trial analysis. 

• In depth observation, knowledge and characterization of trials that enables deep insight into trial quality, plant performance and the environmental context relating to the trial outcomes. 

Competencies

• Planning, conducting, analyzing and interpreting agricultural research field trial data. 

• Central objective of team success, shared goals, and bridge-building across departments, partner companies, and customers.  

• Demonstrated strength in development and management of a strong team. 

• Strong organizational and communication skills. 

• Proven ability to establish and maintain strong internal and external collaborative relationships. 

• Proficiency in use of one or more field research trial planning, data management and analysis platform. 

• A highly goal-focused and schedule-focused approach to work. 

• Successful track record in managing substantial projects with complex interdependencies. 

• Outstanding leadership, motivational, interpersonal, and communication skills. 

• Passion for working in an extremely dynamic, execution-focused, entrepreneurial, small company atmosphere. 

Background, critical knowledge and job requirements

• A graduate degree (PhD or MS) in agronomy, plant breeding or related area and a minimum of 5 years’ experience running a field research program 

• Extensive experience with the analysis and interpretation of field trial data 

• Demonstrated competency in statistical analysis methods and interpretation 

• Proven capability managing employees, external collaboration and internal stakeholder relationships 

• Strong commitment to ethical and legal compliance 

•  Ability to travel up to 35% of the time (mostly domestic with some international travel required) 

• Ability to use MS Office programs and/or other standardized computer tool platforms 

• Ability to learn and use proprietary systems for data management, reporting and other job related functions 

• Ability to work under typical field research conditions
• A valid driver’s license
• email resumes to:    dirfieldtrial@symbiota.com

Mission Statement

Symbiota is pioneering microbial solutions for Agriculture. By unlocking the beneficial microbes that naturally live within healthy plants, Symbiota is developing breakthrough products that harmoniously work with plants to naturally promote crop health and performance.  Symbiota has built the first platform for microbiome product discovery in globally important crops, including corn, soy, wheat, cotton, and vegetables. Product Development plays a cornerstone role in advancement of outcomes from our discovery program towards commercialization and enhancing our understanding of performance interactions and drivers.

Symbiota is currently expanding its field trialing and product development capabilities to support development and advancement of our product leads and to enable the development of data/knowledge assets that enable optimization of our efforts spanning discovery, development, commercialization and product use.

Role Purpose: The purpose of the Field Trialing Associate is to support and implement field trialing efforts and to enable accomplishment of associated goals for the precision, quality and efficiency of Symbiota field trialing efforts in support of agreed business needs and priorities.

Outcomes

1. Timely/quality execution of field trialing programs and related data and/or sample collection.

1. A motivated, capable and high quality contractor network capable of reliable delivery of field trial outcomes.

1. Operation of an efficient and reliable trialing platform that meets our evolving field trial needs.

1. A reliable and efficient field trial process that spans trial planning, trial implementation, data collection, data quality control and routine trial analysis.

1. In depth observation, knowledge and characterization of trials that enables deep insight into trial quality, plant performance and the environmental context relating to the trial outcomes.

Responsibilities for the Field Trialing Associate

• Support implementation of the Symbiota field trialing efforts including trial planning, materials preparation, trial design, data input, note taking, data quality review and routine data analysis

• Serve as a resource and consultant for field trialing cooperators relative to their successful implementation of contracted field trial support

• Recruit, hire, train and manage 3-5 direct seasonal staff

• Support and/or lead field trial effort in plant sampling and other related tasks

• Monitor trials relative to environmental conditions, plot quality, developmental considerations and timely data collection and reporting

• Communicate trialing protocols and standards to Symbiota trialing cooperators and monitor compliance to those standards and protocols

• Support implementation of trial cooperator training and milestone tracking process

• Ensure timely data collection, data quality control/release and the routine analysis of trials

Competencies

• Ability to work in a team environment and efficiently support planning, implementation and analysis of agricultural research field trials.

• Strong organizational and communication skills.

• Proven ability to establish and maintain strong internal and external collaborative relationships.

• Ability to use one or more field research trial planning, data management and analysis platform.

• A highly goal-focused and schedule-focused approach to work.

• Central objective of team success, shared goals, and bridge-building across departments, partner companies, and customers. 

• Passion for working in an extremely dynamic, execution-focused, entrepreneurial, small company atmosphere.

Background, critical knowledge and job requirements

• A four-year degree (BA or BS) in agronomy, plant breeding or related area and 1-3 years of experience with field research programs

• Experience with the collection and analysis of field data

• Proven capability for collaboration in work or academic settings

• Strong commitment to ethical and legal compliance

•  Ability to travel up to 35% of the time in support of field trialing activities, collaborator interactions and visit to corporate offices.

• Ability to use MS Office programs and/or other standardized computer tool platforms

• Ability to learn and use proprietary systems for data management, reporting and other job related functions

• Ability to work under typical field research conditions

• A valid driver’s license
• To apply send email to:   fieldtrialassoc@symbiota.com

Summary:
The Safety Scientist is responsible for supporting Risk Management Lead in the successful conduct of risk management activities, including preparation of regulatory submission documents (Risk Management Plan, Benefit Risk profile, Integrated Safety Summary), periodic safety documents and conduct of safety signal activities.

Responsibilities:
The Safety Scientist will work cross-functionally with groups external to develop timelines and obtain deliverables for: regulatory documents, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP); regulatory agency and other ad hoc queries.

Additional responsibilities:
1. Medical review of cases in the safety database.
2. Participate in tracking and documentation of signal management activities 
3. Represent Global Drug Safety in various cross-functional task forces assigned for the product.
4. Regularly interacts with personnel external to Global Drug Safety (GDS) on matters concerning specific compounds or problems. Interaction normally requires the ability to gain cooperation of others, conducting presentations of RM related information concerning specific projects or schedules

Additional responsibilities for the Specialist
1. Participate in safety database queries and assist in review and tabulation of query output for: SMT meetings, signal management activities, preparation of regulatory documents, regulatory agency and other ad hoc queries.
2. Participate in drafting test for query responses and regulatory documents.
3. Participate in tracking and documentation of signal management activities
4. Interacts with personnel external to GDS on matters concerning specific compounds or problems. 
Requirements
Pharm D or PhD.
At least 4-5 years of experience in drug safety – risk management arena. Experience developing risk management plan and post marketing study designing.

Associate Scientist, Cellular Immunotherapy

Fast growing gene therapy start up

bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.

Join bluebird bio’s enthusiastic and collaborative Cellular Immunotherapy team by contributing to the overall success of our novel gene therapy approach. This new Associate Scientist will join our group to develop and evaluate novel cellular immunotherapies for clinical applications. 

Primary responsibilities:

• Use lentiviral vectors to genetically modify freshly isolated T lymphocytes
• Expansion and maintenance of gene modified T cell cultures
• Characterize genetically modified primary T lymphocytes using standard immunological assays that include ELISA and flow cytometry
• Maintain a lab notebook and contribute to supportive documentation when necessary. 
• Contribute to experimental design and project direction
• Provide critical lab support while working in a collaborative team environment

Requirements 

• BS/MS cell biology, immunology or related discipline with 2+ years' experience in immunology.  Cancer immunology a plus.
• Expertise in mammalian cell culture is necessary. Experience with culture of human T lymphocytes is a plus.
• Experience with standard immunological assays is a plus.
• Excellent computer skills including experience with Microsoft Excel and Graphpad Prism.
• Experience acquiring and analyzing flow cytometry data. 
• Proven ability to effectively plan and organize work activities to meet schedules and deadlines
• Effectively work independently and as part of a collaborative team comprised of multiple functional groups
• Capable of working flexibly in a highly dynamic field that directly impacts patients. 
• Understanding of safe lab practices and BSL requirements 
• Superb organizational skills and “do-what-it-takes” attitude
• Capable of critical thinking and problem solving.
• Excellent oral and written communication skills.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, b yourself

This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular.  bluebird bio is a publicly traded company on the NASDAQ  Global Select Market and trades under the symbol BLUE.  We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.

This is an excellent opportunity within a fast paced Human Resources department. The primary focus of this position is the support and maintenance of the Human Resources Information System (HRIS) called Workday, as well as the responsibility of the day-to-day benefits program. This position serves as a technical point-of contact for ensuring data integrity, testing of system changes, report writing and analyzing data flows for process improvement opportunities. The Human Resources HRIS, Benefits, and Compensation Analyst must be accurate, organized, and detail orientated. As this role is outwardly facing, the candidate must have exceptional customer service skills.

 Responsibilities 

• Perform data analysis and periodic system audits to ensure data integrity
• Assist in the review, testing and implementation of HRIS upgrades
• Manage, maintain, generate and analyze periodic as well as ad-hoc reports on employee data from HRIS
• Process new hires, terminations, leaves and changes in the HRIS timely and accurately
• Ensure accuracy of all benefit enrollments in HRIS
• Deliver new hire benefits orientation and manage enrollment as part of the onboarding process
• Administer various employee benefit programs, including medical, dental, vision, life insurance, disability, 401(k), wellness, etc.
• Review health and welfare monthly invoices for accuracy and work with carriers and benefits broker to reconcile discrepancies
• Coordinate annual open enrollment, health fairs, various training sessions, and other employee wellness events
• Respond to employee inquiries regarding benefits questions, policies, procedures, and programs
• Participate in compensation surveys and complete compliance filings
• Responsible for benefit and compensation related communications (emails, posters, brochures, etc.)
• Assist with annual performance management process including system setup, auditing of reviews and compensation recommendations, and analysis of company-wide data

 Relationships 

• Reports directly to the HRIS, Benefits, and Comp Manager
• Work closely with Human Resources team on various projects
• Act as Payroll liaison to ensure data integrity and efficiencies between both departments
• Close relationship with benefits broker and all benefit vendors
• Work closely with all employees on HRIS and/or benefits related inquiries

Required Experience 

• Bachelor’s Degree in Business and/or Human Resources Management
• Two+ years of HR experience (including benefits experience)
• Experience with an HRIS required; Workday system experience is a plus
• Proficient in Microsoft Office; particularly Excel
• Exceptional analytical and problem-solving skills required; Solution orientation a must.
• Strong understanding of HR processes and data
• Demonstrate success working with detailed information requiring precision and accuracy
• Able to multitask and prioritize activities with changing business needs
• Ability to adhere to and meet deadlines
• Ability to self-manage
• Effective organizational and interpersonal skills including written and verbal communication skills
• Strong judgment and critical thinking skills required; Ability to raise issues proactively and in a timely manner.
• Experience in handling sensitive, confidential information

PRIMARY ROLE: The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. May mentors team members and more junior staff and may direct activities of contract Data Manager staff.

RESPONSIBILITIES:30% Delivering Excellence: Takes leadership role in project implementation
* As a member of the clinical study or project team, ensures oversight of the Data Management CRO ; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO
* Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
* Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards
* Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance

25% Accountability and Ownership: Drives accountability at every possible level
* Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire's quality standards and SOPs
* Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance

15% Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
* Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve

10% Courage to challenge: Takes risks and challenges norms to support tomorrow's needs
* Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations

10%
* Serving Customers;Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making
* Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams' long-term needs are addressed.

10%
* Building Authentic Relationships: Building trusting relationships that will enhance current and future needs

EDUCATION AND EXPERIENCE REQUIREMENTS:
* B.S. degree in Scientific or related field is preferred.
* Minimum of 5-7 years as a Sr. Data Manager within a Data Management organization
* Experience with leading teams and/or organizations.
* CCDM certification preferred

KEY SKILLS, ABILITIES AND COMPETENCIES:
* Must be able to produce data management reports
* Strong attention to detail and accuracy is a must.
* Ability to read, analyze and interpret complex technical documents.
* Ability to present complex issues in oral and written form.
* Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.
* Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community.
* Proven ability to manage and communicate effectively with research vendors including reviewing request for proposals, analyzing scope of work, budgeting and forecasting, responding to inquiries and complaints.
* Demonstrated ability to prioritize across work assignments.
* Proven ability to independently resolve problems.

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=c3N6Y3plc255LjQzMTI0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Duties
Assist with operational management of one or more GMA programs, systems, and services Potentially including Investigator-Initiated Research, Independent Medical Education Grants, and RnD Select/HCP Engagement Support GMA project development/harmonization, implementation, modifications and optimization, including alignment of processes and systems to the requirements of GMA, Legal and Compliance partners

Support management of system vendors and addressing of GMA team requirements Identify areas for process improvement, propose changes, and participate in implementation as appropriate

Responsibilities
70%
* Assist with operational management of one or more GMA programs,
* systems, and services
* Assist with management of projects and processes for assigned
* therapeutic areas and geographies, including daily management of
* review and approval processes, contracting, budget management,
* metrics tracking, and participating in vendor management
* Collaborate with GMA Operations Lead, GMA teams, Legal and
* Compliance partners to define system and process requirements
* Support GMA Operations Lead in defining approaches to harmonize
* legacy processes and/or define requirements for new GMA processes
* Support the identification of best practices for project management

20%
* Assist with definition and management of procedures, communication
* and training for relevant GMA Operations
* Provide input into the development SOPs, procedures and training for
* use of projects and processes by Global Medical Affairs team
* members
* Support definition of periodic communications regarding project
* updates and milestones
* Support definition and delivery of skills and compliance training for
* GMA Operations system users
* Track project performance in terms of goals and delivery of services
* to internal customer

10%
* Track and report project performance
* Under guidance from GMA Operations Lead, define relevant systems
* metrics and reporting process
* Per the defined process, track and report project metrics to GMA and
* other Shire stakeholders

Education and Experience Requirements:
* A relevant scientific Bachelor's degree (BS or BA) is required,
* An advanced medical or science degree (e.g. MD, PharmD, RN, Masters, PhD) is preferred
* >3 years of experience in the biopharmaceutical industry, preferably within a matrix structure is required
* >1 years of experience managing and/or developing grant and/or service provider engagements is required
* Experience of executing projects is required
* Experience of managing vendors is preferred
* Knowledge of medical affairs customer interaction and documentation best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines is required

Other Job Requirements
* Availability to travel approximately 10% 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=amRpZXR6LjQ3ODYwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role:
The Zone Director (ZD) for LSD is responsible for the implementation of the strategic initiatives developed in partnership with the leadership team for the promotion of VPRIV® for Gaucher Type 1 Disease and Elaprase® for Hunters Syndrome (MPS II) within approved labeling. The ZD will develop deep understanding of the business situation within their geographic responsibility. They will manage and develop a top preforming team. They will:

Drive results
* Work with salesforce to prioritize key accounts
* Monitor and report on short-term and long-term goals of zone
* Allocate resources and secure additional resources as necessary to support salesforce activities
* Maintain an in-depth understanding of the market by reviewing and analyzing market data and use this market/industry know-how to drive success

Translate and implement strategy
* Assist home office in developing an effective strategy
* Translate strategy into actions and objectives for salesforce and take an active role in communicating and reinforcing strategic vision to salesforce
* Hold regular meetings to help salesforce better understand strategies and objectives and implement sales tactics

Partner internally and externally to the business
* Serve as a liaison between the field and home office; prioritize and communicate relevant issues and ideas
* Work collaboratively with home office (e.g. training, marketing, reimbursement) to effectively develop the most effective plans, processes and programs for the product
* Advocate Shire and the product to KOLs, physicians, and patients

Develop and lead effective sales force
* Problem-solve with salesforce to identify ways to add value/help influence customers
* Motivate salesforce to maintain passion for the mission and value of the product's capabilities
* Build team and company commitment within area
* Monitor performance, recognize top performance and address performance issues
* Provide continuous performance feedback, coaching, development and mentoring of salesforce

Responsibilities:
* 60%: Responsible for meeting and exceeding sales objectives. This includes, but is not limited to effective hiring of top talent, effective implementation of the fundamentals of selling and implementation of the marketing plan.
* 20%: Responsible for coordinating with broader commercial team (Marketing/Reimbursement/Patient Services) for the design and implementation of the U.S. business plans
* 20%: Effectively assesses the development needs and initiates activity that will further develop Salesforce members.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required.
* Minimum of 5 years experience as a sales representative, within substantial orphan and/or hospital therapy sales success
* Previous experience as a first line manager

Other Job Requirements:
* Must live in zone
* Travel required 65%.

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=bHZhaWwuMDEyMDEuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

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 VPRIV® for Gaucher Type 1 Disease and Elaprase® 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 selling specialty 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 Northern California and Reno, NV

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=bHZhaWwuNDYwODguMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Role:
The Regional Disease Education Manager (RDEM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RDEM will educate and raise awareness of specific Lysosomal Storage Disorders, Gaucher Disease and Hunters (MPS II) Syndrome, with health care providers in a defined geography to uncover patients that are appropriate for Shire's therapies. The RDEM will be expected to meet or exceed set expectations related to patient identification and the development of a robust sales funnel. Further, once an appropriate patient/provider is identified the RDEM will partner with the Regional Business Manager (RBM) to assist with the steps necessary to get the patient on drug.

Responsibilities:
This position will be responsible for all disease education related activities within their geographic responsibility, including achievement of MBO's, business planning in partnership with the RBM, and expense control. The RDEM will educate and inform HCPs on Gaucher Disease and Hunters (MPS II) Syndrome. They will describe signs and symptoms of the diseases and inform on the differential diagnosis process. They will educate HCPs on the appropriate treatment referral route. They will attend conferences and workshops as an exhibitor or presenter.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required
* Healthcare provider, Nursing, Genetic Counselor background preferred
Minimum of 4 years of sales experience required
* Minimum of 2 in specialty biologics preferred
Complex sales model experience is preferred
* A consistent track record of success (Top 20% performance), President's Club or other top tier awards preferred
* Experience providing complex disease education preferred
* Rare disease experience is a plus
* Demonstrated pioneering experiences required

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 Oregon

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=bHZhaWwuNTA1ODAuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Duties:
Associate Director, Regualtory Affairs, Advertising and Promotion serves as an internal expert on FDA regulations governing the promotion of prescription pharmaceutical products. The role is repsonsible for supporting the PPM, MLR, CPR, and Publications review processes and thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Shire policies. Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, and Commercial organization and applies expertise to insure promotional materials development is accomplished following the Shire Promotional Development Process.

Responsibilities:
50%
Provides regulatory evaluation of all proposed promotional materials presented for MLR, CPR, and Publications review processes for assigned brands. Evaluates draft materials to insure compliance with FDA promotional regulations, OPDP Guidance documents and enforcement letters, corporate standards and policies and business objectives. Conducts detailed review and evaluation of adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved prescribing information, researches OPDP guidances, advisory comments, enforcement letters, and public statements related to proposed claims. Works collaboratively with Medical and Legal colleagues to achieve alignment. Summarizes regulatory background and recommeds approval or non-approval.

25%
Supports interactions with FDA/OPDP including conduct of background investigations required to support response to regulatory inquiries or enforcement actions. Drafts regulatory submissions for advisory comments and advises Marketing and Advertising Agencies in development of supporting materials. Insures necessary actions are completed througout the company when changes to prescribing information and/or safety information occur and when changes to promotional claim structure are mandated by FDA or by Shire management. Tracks activities of Marketing and Marketing Services and maintains thorough documentation of actions taken in response to regulatory actions.

15%
Builds and maintains a thorough understanding of OPDP requirements and regulatory interpretations. Maintains a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Interprets and communicates FDA perspective to relevant stakeholders. Develops and delivers regulatory and policy training to colleagues in Medical, Legal, Commercial and Vendors.

10%
Participates in activities to develop and insure adherence to Shire policy, process and standards for promotional development and promotional compliance. Assists in evaluations of process compliance, process effectiveness, and process effiiciency and recommends process changes as needed. Responsible for driving and evaluating compliance with Promotional Materials Development Process (PMM). Addresses non-compliance through provision of remedial training and/or process adjustments as appropriate. Assists Marketing in planning and prioritization of materials for review.Maintains current and accurate copy of Core Claims Guide (CCG) and complete OPDP correspondence binders for assigned brands.

Education and Experience:
* Education Minimum Requirement: B.A. or B.S. degree

Required Experience and Skills -
* 5 years experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines
Desired Experience and Skills - Experience reviewing and approving pharmaceutical/biologics promotion; BA, BS or advanced degree with an emphasis in science, health care or related fields, MBA

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=amRpZXR6LjMxMTczLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t