- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GPT Leader , directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has end-to-end ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...rare diseases and immune disorders. Summary The Global Team Leader , is a senior, cross-functional leader in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: For ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Catalent (St. Petersburg, FL)
- Associate Scientist I II , Product Development Position Summary Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... development and manufacturing challenges . The Associate Scientist III, Product Development contributes significantly to the successful timely development of… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product...monitor screen frequently. Why You Should Join Catalent Competitive medical benefits and 401K 152 hours of PTO +… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product safety lead or part of a product safety ... team, and be responsible for overall product safety strategy or specific areas of safety ...Depending on the status of development of the compound, lead and medical -scientifically direct a team of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized… more
- Catalent (CA)
- Account Executive, Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an Account Director, Pharmaceutical Softgel and Late-Stage Oral Solids. This ... career path and annual performance review and feedback processCompetitive Medical , Dental, Vision, Life Insurance, and 401K19 days PTO...your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... risk management tools and resources.Responsibilities- Strategic Advice and Support to Global Product Teams: 1) Provides expert, strategic advice on the creation and… more
- Eisai, Inc (Nutley, NJ)
- …responsible therapeutic areas. Medical /Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for assigned ... grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, … more
- Eisai, Inc (Nutley, NJ)
- …responsible therapeutic areas. 30% Medical /Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for ... grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, … more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.II. Basic Function: This position is ... managing and documenting events / discrepancies associated with either product or process as well as managing / writing...when production events occur as defined by SOP and lead cross functional team to classify events and deviations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and...collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …advice to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure ... limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion Diagnostics/ Device Laboratories… more
- Aequor (Thousand Oaks, CA)
- …Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for complex product ... documents, following applicable standard operating procedures With limited supervision, lead regulatory writing activities for complex product submissions,… more
- Catalent (Philadelphia, PA)
- …reviewing and approving batch records, and releasing batch records and finished product . They will have a deep understanding and values around patient and ... employee safety , will assist in the enforcement of GMPs and...network. Packaging can be configured to hold a single product or multiple products as determined by study requirements.… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact ... limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label and… more
- Catalent (Manassas, VA)
- …and requirements. Verifies and keeps records on incoming and outgoing product & material movements, accurately. Process daily, weekly cycle counts.Location: ... shipping documents ie BOL, packing list, pro-numbers. Assembles and inserts product into cardboard containers or selects pre-assembled containers; Posts weights and… more
- Novo Nordisk Inc. (Durham, NC)
- …Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & ... Benefits including 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life… more
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