- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ Authors safety data summarization of applicable information for New Drug Applications (NDA), New Drug Submissions (NDS), Amendments, Supplements, ... safety topics for products working closely with Drug Safety Global Safety Team...[Periodic Safety Update Reports (PBRER, DSUR, PADER), safety sections for labels/IBs/regulatory submissions (eg, IND/pre-NDA… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. Manages Drug Safety Data Systems to ensure the timely creation, deployment and ... maintenance of databases required by MTDA Drug Safety projects. Analyzes study protocol and...a combination of education and experience + 8+ years pharmaceutical experience in clinical and/or safety setting… more
- Endo International (Malvern, PA)
- …setting. Advanced Degree preferred. + Eight (8) years of experience in pharmaceutical drug safety /pharmacovigilance case processing including branded and ... + Monitor workload and workflows to ensure on time submissions to regulatory authorities and partners + Guide vendor...computer literacy, particularly in the use and management of Drug Safety databases including ICSR data entry,… more
- Novo Nordisk (Lexington, MA)
- …speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds ... Nonclinical Development department with cross-functional scientific expertise, including toxicology, safety pharmacology, PKPD, ADME, outsourcing management, and non-clinical project… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …the best of my knowledge. **Job Description** Job Title: Principal Scientist - Drug Substance Location: Thousand Oaks, CA **About the role:** The Principal Scientist ... Be the subject matter expert for audits, change controls, and regulatory submissions . + Assist and own Validation Master Plans, Process Validation and Material… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions . This individual will ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...rare diseases and immune disorders. **Summary** The Director, Clinical Safety , will be a product safety lead… more
- BeiGene (San Mateo, CA)
- … queries from ethics committees + Lead the authoring and review of safety sections of regulatory submissions , eg, IND/CTA (General Investigational Plans, China ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… more
- AbbVie (South San Francisco, CA)
- …conduct safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug -device combined products + Lead and set ... safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions ,...lead role equivalent) / Clinical Development experience in the pharmaceutical industry required + Oncology experience strongly preferred +… more
- Takeda Pharmaceuticals (Boston, MA)
- …on programs with complex business deliverables + Operational experience in pharmaceutical drug development with significant direct exposure to clinical ... Join us as the Head, Analytical Development (AD) in Pharmaceutical Sciences. At Takeda, we are transforming the ...methods and analytical testing data for IND/CTA to NDA/MAA submissions in countries across the world that will serve… more
- AbbVie (North Chicago, IL)
- …specifications in accordance with analysis plan. + Provide strategic input on safety related submissions to regulatory agencies and responses to requests ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Safety Statistics provides scientific and strategic input and safety … more
- AbbVie (Boston, MA)
- …guidance to team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products. This role is directly responsible ... safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions . + Leads a team of statistical… more
- Pfizer (Chesterfield, MO)
- **Why Patients Need You** Pfizer believes in holding the highest standards of safety for its patients and its employees. Your role, as a member of the Global ... team, and as the Chesterfield site Environmental, Health and Safety Lead, is important for maintaining these standards and...all routine and special regulatory and internal reports / submissions . + Serve as the primary point of contact… more
- BeiGene (Emeryville, CA)
- …reports, eg, PBRERs, DSURs, PADERs + Support the authoring and review of safety sections of regulatory submissions , eg, IND/CTA (General Investigational Plans, ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… more
- Catalent Pharma Solutions (Bloomington, IN)
- …facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning ... high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new...facility helps customers accelerate biologic drug development programs and bring better treatments to help… more
- Boehringer Ingelheim (Ridgefield, CT)
- …in the assigned therapeutic area from the global regulatory, scientific, pharmaceutical , pharmacovigilance, market access and commercial perspective as well as ... TA and a broad range of global regulatory and drug development topics. + Seamlessly interact and collaborate cross...lifecycle. + Oversee the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager. + Support… more
- Catalent Pharma Solutions (Hillside, NJ)
- …is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients ... a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The primary duty of the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC ... both local and international, related to the clinical medicine and drug development processes. The Director, I&I will lead multidisciplinary teams, mentoring… more
- Bristol Myers Squibb (Cambridge, MA)
- …and drug -interaction potential of drug candidates. Working closely with drug safety and clinical pharmacology, Dev DMPK plays a critical role in ... IND submissions and marketing authorization applications. We utilize our deep...DMPK group that is an expert in ADME and pharmaceutical drug development of protein therapeutics and… more
- University of Washington (Seattle, WA)
- … Administration (FDA), the Institutional Biosafety Committee, the institutional Radiation Safety Committee and the pharmaceutical sponsor, funding foundation or ... will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor...the research, the reputation of the institution, and patient safety . This position may work with minimal supervision and… more
- United Therapeutics (Durham, NC)
- …manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). ... future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability...to ensure the successful submission and approval of a drug product by regulatory agencies. This is a hybrid… more