- Alkermes (Waltham, MA)
- … regulatory submissions. Collaborate cross-functionally with Biostatistics, Clinical Operations, Clinical Research , Regulatory Affairs , and other ... in life sciences preferred. 5+ years of relevant medical writing experience in clinical research , including protocol and CSR writing. Strong understanding of ICH… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Merck & Co. (Rahway, NJ)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories ( Research & ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute… 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 ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary: This position manages… 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 ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsibility for… more
- Cedent (Boston, MA)
- …Experience: Minimum 5 years in clinical research with 3+ years in regulatory affairs at a CRO or sponsor. Certifications: RAC ( Regulatory Affairs ... CRO Regulatory Specialist Job Description The Regulatory Specialist ensures clinical trials operate...Education : Bachelor's degree (required) in Life Sciences, Pharmacy, Regulatory Affairs , or related field. Master's degree… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... 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… more
- Olema Oncology (San Francisco, CA)
- …research , biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical Proven 3-5 ... label implementation. This role will work closely internally with Regulatory Affairs , Clinical Development, ...and the CMC teams as well as external vendors ( clinical research / development and manufacturing organizations)… more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out… more
- Boston Scientific (Maple Grove, MN)
- …pipeline, and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of the ... Interventional Cardiology Regulatory Affairs...discipline within the medical device industry (eg, R&D, Quality, Clinical , Medical Affairs , Biocompatibility) Introductory knowledge of… more
- Abbott (Minneapolis, MN)
- …experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. ... and get on with their lives. The Opportunity The Regulatory Affairs Manager will work on-site at...regulatory submission to authorities. Evaluate risk of and regulatory solutions to product and clinical safety… more
- Boston Scientific (Maple Grove, MN)
- …required Required qualifications: Minimum of a Bachelor's Degree 7+ years of experience in Regulatory Affairs , or 5+ years of experience with an advanced degree ... filings Technical and labeling reviews of supporting documents for inclusion in regulatory filings Review of clinical study protocols and other clinical… more
- University of Kansas Medical Center (Kansas City, KS)
- …(CFR, GCP, HIPAA). Experience with statutes and guidelines relevant to regulatory affairs in clinical research . Experience study budgets, contracts, and ... Department: SOM KC Cancer Center Clinical Trials Administration Position Title: Clinical Research Coordinator - Cancer Center Job Family Group: Professional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing assessments Improve ... About the Department The Clinical , Medical and Regulatory (CMR) department...Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory responsibility for field based Medical… more
- Boston Scientific (Marlborough, MA)
- …than 50 percent of all urology surgical procedures. This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance ... discipline A minimum of 1 year work experience in Regulatory Affairs or 2 years work experience...work experience in a related discipline (eg, R&D, Quality, Clinical , Medical Affairs , Biocompatibility) in the medical… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …and execute regulatory plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ... documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals Research and analyze regulatory … more
- Organon (Plymouth Meeting, PA)
- …questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of ... project timelines. Preferred Experience and Skills A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Abbott (Pleasanton, CA)
- …international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory ... female executives, and scientists The Opportunity We are seeking a Regulatory Affairs Manager to join Abbott's Heart Failure Division on-site in Pleasanton,… more
- Apex Systems (San Diego, CA)
- …experienceina research position at amedical device or biotechnology company, clinical research organization, or research institution(or theequivalent ... JOB DESCRIPTION Position Overview We areseekinga motivated and detail-oriented Research Assistant to join our Medical Affairs team. This role will support… 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 ... Senior Director has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines.… more
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