- Cedent (Boston, MA)
- As a Clinical Trial Regulatory Affairs Specialist, you will be responsible for: * Regulatory Compliance: Ensuring all clinical trials adhere to ... 4. What We're Looking For *Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement… more
- Merck & Co. (Rahway, NJ)
- …, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... and effective implementation and oversight model to maintain best in industry regulatory compliance.The Vice President Regulatory Affairs , General Medicine… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global ... Medical Affairs /MSL training and continued education plans related to Eisai's...regional medical directors and MSL leadership, Publications, Medical Communications, Clinical Development, Biostatistics, Field HEOR, Patient Advocacy, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… 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
- Pivotal Solutions (Boston, MA)
- …in alignment with company objectives. Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs , and Marketing, to ... in Medical Affairs . Strong knowledge of relevant therapeutic areas, clinical research methodologies, and regulatory requirements. Proven leadership skills… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …regarding patient consent. Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of ... strongly desired. PREFERRED QUALIFICATIONS: Master's degree in regulatory affairs . Certified IRB Professional (CIP) certification. Previous clinical research… 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
- Merck & Co. (Rahway, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical ... Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's… more
- Leica Biosystems (Miami, FL)
- …digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work ... about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development… more
- Glycomine (Boston, MA)
- …Oversight Plan, etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and ... and evaluation of adverse events and product safety issues. Oversee clinical and regulatory files, including the essential Trial Master File (TMF). Work… more
- eGenesis (Cambridge, MA)
- …integrity in all clinical programs Work with internal stakeholders including Clinical Development, Regulatory Affairs , Non- Clinical , and ... across the pipeline. The Clinical Scientist will work cross-functionally with Clinical Operations, Regulatory , Pre- Clinical and Translational to execute… more
- Beth Israel Lahey Health (Boston, MA)
- …Outlook, Word, Excel, PowerPoint or Access. Preferred Qualifications: 1-3 years of clinical trial regulatory affairs experience preferred. Competencies: ... SOPs. Required Qualifications: Bachelor's degree required; Master's degree preferred in Regulatory Affairs . 1-3 years related work experience required. Must… more
- Merck & Co. (North Wales, PA)
- …and reimbursement. 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 provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …point of contact between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education ... Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or...Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action… more
