- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director, Global Medical Affairs Training and Education is from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Merck & Co. (Rahway, NJ)
- …HTA submissions. The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and ... and barriers to reimbursement and market access, and provide input into clinical , regulatory , payer/access, marketing and evidence generation strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within… more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …care, be real, get it done, and have fun, seriously. POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects ... preparation of regulatory documentation in support of Regulatory Authority Interactions (briefing books). Support the Clinical...industry with a minimum of 8 years in Global Regulatory Affairs , experience with major Health Authority… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …global drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for marketed products and compounds in ... three days per week on average. Position Summary The Associate Director, Regulatory CMC, is responsible for...least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …she should have an understanding of pharmaceutical drug development including clinical development, regulatory , life cycle management of pharmaceutical products, ... in the disease area within the pharmaceutical industry, such as within Medical Affairs or Clinical Development Strong interpersonal and communication skills to… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …bring different and innovative ways of seeing the world and solving problems. The Senior Regulatory Affairs Associate works with faculty and staff in the ... consent. Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of new impacts/areas of… more
- AbbVie (North Chicago, IL)
- … compliance, and contributes to the overall success of drug/device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the ... products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie's evolved business strategy are complex, rapid… more
- Eli Lilly and Company (Washington, DC)
- …leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers Engage in forums that share regulatory ... regulatory risk, and improve efficiency in drug development. The purpose of the Associate Director - Global Regulatory Policy & Strategy is to support… more
- eGenesis (Cambridge, MA)
- …integrity in all clinical programs Work with internal stakeholders including Clinical Development, Regulatory Affairs , Non- Clinical , and ... SUMMARY eGenesis is seeking a highly motivated and experienced Associate Director of Clinical Science to join...The Clinical Scientist will work cross-functionally with Clinical Operations, Regulatory , Pre- Clinical and… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... true to the best of my knowledge. Job Description Associate Director, Clinical Research, Value & Evidence...development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWE Epidemiology Legal and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a high performing team ... rare diseases and immune disorders. JOB SUMMARY The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the… more
- Vanderbilt Health (Nashville, TN)
- …patient care, education, and research. Organization: Quality Admin Job Summary: The Associate Director supervises, coordinates and monitors the work activity of a ... The VUMC Quality Administration Laboratory Department is in need of a Associate Director to join the team! Department Summary: Our new 110,000-square-foot diagnostic… more
- Corcept Therapeutics (Redwood City, CA)
- …support, focusing on publication strategy and execution for Oncology Medical Affairs -led publications in tandem with Clinical Development-led publication ... by maintaining deep knowledge of the therapeutic area, product landscape, and relevant clinical data to inform Oncology Medical Affairs strategies across launch… more
