- Catalent (St. Petersburg, FL)
- …regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation ... based on trend analysis to eliminate future problems. Participates in Product Development /Validation/Engineering project meetings to provide Quality Assurance… more
- Lundbeck (Miami, FL)
- …or business development partners Executes on MSL goal and objectives and Medical Affairs product plans Applies advanced field-based medical and ... Rico POSITION SUMMARY:The Senior MSL, Neurology will apply advanced field based medical and scientific experience, subject matter knowledge, and skills in supporting… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that ... medical device company and a leader in new product development and medical education...Bachelor's degree required, preferably in business, engineering or clinical. Master 's degree preferred. Five or more years' experience in… more
- Novo Nordisk Inc. (Boulder, CO)
- …a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi ... Early Development professionals at our Boulder, Colorado facility and works...Line of Business in developing project roadmap & area master plan. Indirect reporting to CMC Leadership with 1:1s,… 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 ... veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the day-to-day direction ... to Medical Safety Team to ensure business needs and priority...and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position… more
- Aequor (Thousand Oaks, CA)
- … Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams Participate in departmental ... reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the Summary of Clinical Efficacy,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including (mAb, Drug Substance, Drug Product , or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (North Wales, PA)
- …BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development Division ... Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, Statistical Programming, , and other company Research… 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 ... leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...defined based on the project needs and the respective development stage of the project. The CMC Lead will… more
- Catalent (San Diego, CA)
- …quality systems requirements and applicable regulatory requirements; to advance the development and manufacture of drug candidates. This will include documentation ... review and approval, dispositioning of product or its intermediates & supporting manufacturing operations.This position is 1st shift Monday-Friday from… 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 ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position… more
- Catalent (Harman, WV)
- …of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and ... requirements and standards The Candidate Bachelor's degree with 12-14 years or Masters ' degree with 10-12 years in a Scientific, Engineering or Biotech field… more
- Merck & Co. (Rahway, NJ)
- …state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs ... activities and in application of novel methods to clinical trial development .--Publications in peer reviewed statistical/ medical journals.-Must also demonstrate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with global functions including but not limited to Commercial, Marketing, Medical , Clinical Development , Public & Government Affairs.Responsibilities- Lead the ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Lundbeck (Philadelphia, PA)
- …pharma commercial function Rare disease or biologics infusion experience Pharmaceutical / medical / healthcare product brand marketing or other commercial ... Customer Engagement, Patient Acquisition, Market Access, Marketing teams, and Medical ) todevelopand implement strategies for Lundbeck products tomaximizeproduct access… more
- Lundbeck (New York, NY)
- …for promotedproducts within an assigned geographic area. Set and lead the development of area strategic direction and tactical sales plans using robust analytical ... provider's setting and payer mix. Managing Execution Sets and maintains competent product knowledge and selling skills standards within the team. Manages demand… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development strategies for program/s under IST; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and ... 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)
- …GTL is the GPT Leader, directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has ... functions in support of the asset.Design, maintenance and update of the compound's Integrated Product Development Plans, Target Product Profiles and Target … more
