- 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)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… 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
- 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
- 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
- The City University of New York (Hunter, NY)
- …of Nursing (HBSON) invites innovative and visionary nurse leaders to apply for Senior Associate Dean for Academic Affairs . The HBSON is seeking an exceptional ... and is a key member of the School Executive Leadership Team. The Senior Associate Dean for Academic Affairs will provide leadership in developing and… more
- IntePros (Audubon, PA)
- IntePros is currently looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. The Regulatory ... regulations. Experience should demonstrate dependability, flexibility and attention to detail. Regulatory Affairs Associate Job Requirements: Under… more
- CryoLife (Kennesaw, GA)
- …Clinical Research Associates III, IV, Data Managers ,Project Managers and other Clinical Affairs team members. Qualifications: BA/BS/BSc in a scientific or ... Position Objective: To independently manage and monitor all aspects of clinical trials at investigative sites, ensuring data accuracy and compliance with… more
- Sun Pharmaceutical Industries (Princeton, NJ)
- …M anage HEOR projects across product lifecycles, collaborating with cross-functional teams ( clinical , medical affairs , regulatory ) to support enterprise ... a subject matter expert within the enterprise, working with teams across medical, clinical , regulatory , and commercial functions to support and lead business… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. Working knowledge of GCP, Clinical and Regulatory Affairs . Proficient with Microsoft Suite. Travel ... 160 countries. JOB DESCRIPTION: The Opportunity: The CRA III will assist in the clinical execution and management of all aspects of assigned clinical studies.… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …vendor teleconferences Serve as a primary liaison to internal partners ( Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs ) and ... cultures, perspectives, and experiences to join our team. What You'll Do: The Associate Director, Clinical Data Management plays a key role within the… more
- AccruePartners, Inc. (Charlotte, NC)
- …What They Offer You: Hands-on training & mentorship - Learn regulatory practices with full support from experienced team members. Collaborative, fast-paced ... in office 2 days remote Key Responsibilities: Review scientific literature and clinical studies to support compliant product claims and collaborate with marketing on… more
- BioSpace (Boston, MA)
- …true to the best of my knowledge. Job Description About the role: The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the ... ICH. Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Omni Inclusive (Miami, FL)
- …product registration and/or product market clearance/approval. This position is part of the Clinical Affairs Department for the Clinical Decision Support ... The Clinical Research Associate (CRA) for Beckman Coulter...fully remote. You will report to the Director of Clinical Affairs . You will be part of a… more
- Cedent (Boston, MA)
- Job Overview: We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in ... pharmacy, health sciences, or a related field. 2+ years of experience in regulatory affairs , clinical research, or a related area within the pharmaceutical,… more
