- Takeda Pharmaceuticals (Columbus, OH)
- …of my knowledge. **Job Description** **About the role:** **Associate Director, Nonclinical Regulatory Writing and Submission Support,** **_Oncology and Marketed ... meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission Support_ reporting...corporate policies, as well as work experience, to ensure regulatory compliance by assessing document requirements and… more
- UTMB Health (Galveston, TX)
- …will serve as the single point of study control with overall responsibility for the scientific , technical and regulatory conduct of studies as well as for the ... with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies to design and execute… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Regeneron is seeking a highly motivated **Manager, Scientific Writing** to supervise regulatory submission drafting activities for preclinical pharmacokinetics ... is dedicated to the drafting of submission documents with nonclinical content (PK, Toxicology, and Pharmacology) as well as...attention to detail and in crafting language to distill scientific and regulatory key messages from source… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …assigned early drug development programs andensures cross-functional alignment. + Leads regulatory activities within the project teams ( nonclinical , clinical) to ... regulatory submissions relevant to assigned programs, including coordinating regulatory workflow, reviewing technical documents ( nonclinical , clinical, and… more
- AbbVie (North Chicago, IL)
- …carry out job functions. Preferred: + Experience with relevant software systems, scientific writing and terms, document checking, importation, and workflows in ... thorough quality assessments of published output, ensuring alignment with regulatory standards and health authority guidance. Verify content, including bookmarks,… more
- Vera Therapeutics (Brisbane, CA)
- … and clinical document production. * Support clinical and regulatory document preparation (eg, eCTD modules, briefing documents, study protocols, ... scientifically accurate manner. * Work with functional representatives such as regulatory affairs, clinical and nonclinical development, clinical pharmacology,… more
- Frontier Medicines (Boston, MA)
- …and with external CROs/collaborators. + Co-ordinate authorship, review and approval of scientific reports that support regulatory documents including INDs, CTAs, ... will work effectively with a cross functional team including DMPK, toxicology, regulatory , CROs, and program management. If you are committed to translating … more