- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible ... planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role ... planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge… more
- Bristol Myers Squibb (Princeton, NJ)
- …and successful marketing authorizations across the globe. PCO "is looking for a Scientific Associate Director to join the Dev DMPK group that is an expert ... pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier/responses; and assist in developing strategy for the group.… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Associate Director , Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused ... patients suffering from immunological diseases. Position Summary: Reporting to the Senior Director , Medical Writing, the Associate Director , Medical Writing… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be ... inspections . + External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical… more
- AbbVie (Branchburg, NJ)
- …Purpose Responsible for supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making ... or Development Safety Update Report) for early development assets *Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV… more
- AbbVie (North Chicago, IL)
- …reporting of non-GLP and GLP toxicology studies, acting to support the Study Director and regulatory infrastructure. MAJOR RESPONSIBILITIES: + Draft study plans, ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The position of Associate Scientist, Toxicology Study Coordinator is in the Preclinical...for key tasks in the set-up and conduct of nonclinical studies + Support the Study Director ,… more
- ADP (Alpharetta, GA)
- …by the ADP Corporate Medical Department. + Collaborate with the Medical Director , the Manager- Medical Administration, and the Physician Manager(s) to assure ... compliance with regulatory standards established by federal and state agencies (HIPAA,OSHA,etc)...serve as a member of one of the centralized, nonclinical function committees, and collaborate with other committee members… more
