- ThermoFisher Scientific (Boston, MA)
- …maintaining full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for late-stage and commercial programs ... skills. + Familiarity with commercial program lifecycle, QMS systems, and regulatory submission expectations is preferred + Proficiency in statistical… more
- Merck (Boston, MA)
- …The Principal Scientist is responsible for the preparation and submission of combination product sections of regulatory submissions, correspondences, etc. ... **Job Description** **Director, Combination Product Regulatory CMC - (R5)** This Principal Scientist...Regulatory Strategies and execute on various deliverables for submission and approval of complex investigational new drugs (IND),… more
- Sanofi Group (Cambridge, MA)
- …of toxicity. + Serve as a subject matter expert to assist in authoring of regulatory submission documents and addressing issues or queries from regulatory ... **Job Title:** Senior Distinguished Scientist , Scientific Advisor, Pathology **Location** : Remote **About the Job** Are you ready to shape the future of medicine?… more
- Sumitomo Pharma (Boston, MA)
- …diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more ... . **Job Overview** The Senior Manager, Pharmacovigilance Scientist serves as the primary Pharmacovigilance and Risk… more
- Sanofi Group (Cambridge, MA)
- … environment. + Provide authorship and/or expert review of white papers or regulatory submission documents as needed. + Participate in external cardiovascular ... **Job Title:** Distinguished Scientist , Scientific Advisor Cardiovascular Safety **Location** : Remote, Cambridge, MA **About the Job** Are you ready to shape the… more
- Bristol Myers Squibb (Cambridge, MA)
- …Read more: careers.bms.com/working-with-us . Job Requisition: Senior Principal Scientist , Development DMPK Challenging. Meaningful. Life-changing. Those aren't words ... the globe. PCO is looking for a Senior Principal Scientist to join the Dev DMPK group that is...activities of multiple projects; be responsible for preparation of regulatory dossier / submissions; and assist in developing strategy… more
- Sanofi Group (Cambridge, MA)
- …policies, regulatory nonclinical testing requirements; Writing documents for regulatory submission and interactions with health authorities. Experienced in ... **Job Title:** Distinguished Scientist , Safety Assessment Project Expert **Location** : Cambridge,...responsible for oversight of the nonclinical safety program of Research and Development drug candidates. These activities entail formulating… more
- ThermoFisher Scientific (Boston, MA)
- …individual career goals while taking science a step beyond through research , development and delivery of life-changing therapies. With clinical trials conducted ... in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory,… more
- Sanofi Group (Cambridge, MA)
- …the Global Project Head (GPH), and leading a team of Clinical Research Directors and Clinical scientists. The role requires a well-organized, experienced, strategic ... + Oversee and contribute to the clinical part of submission dossier for their projects: Common Technical Document for...in the project, Global Project Head, The PV Rep, Regulatory + Provide expertise in the fields of clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …data to support development, and + Serving as principal functional author for Regulatory submission , study reports, and publications + Provides oversight and ... interactions for early development projects + Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support… more
- Takeda Pharmaceuticals (Boston, MA)
- …relevant to mechanisms of action of compounds in remit + Regional/global Regulatory requirements + GCP/ICH + Emerging research in designated therapeutic ... (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for multiple Takeda pipeline compounds. Leads… more
- Sumitomo Pharma (Boston, MA)
- …GxP compliance. + Author reports/chapters of reports including those intended for regulatory submission . For example, clinical study reports (CSRs), investigator ... diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more… more
- Takeda Pharmaceuticals (Boston, MA)
- …Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that ... development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency… more
- Bristol Myers Squibb (Cambridge, MA)
- …meetings as Clinical Trial Physician + Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, ... Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management… more