- Syner-G BioPharma Group (Boston, MA)
- …exhaustive and may be supplemented and changed as necessary.) Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, ... Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).Write, review, and… more
- Eisai, Inc (Nutley, NJ)
- …of regulatory strategies for products under development, post-approval activities, and life - cycle management, with a particular emphasis on the regulatory ... Essential Functions Provide strategic leadership in the development, registration, and life - cycle management of products in growth markets. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the activities in the USMA plan including Launch Readiness and Life Cycle Management.ResponsibilitiesResponsible for the development of the US Medical ... scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective.Participates in Global… more
- Formation Bio (New York, NY)
- …role includes the lead regulatory responsibility for support of global registration and life cycle support and the leadership of regulatory strategy for projects ... industry in other areas. The regulatory experience should be broad (across the life cycle of pharmaceutical products, including clinical, non-clinical and CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the activities in the USOMA plan including Launch Readiness and Life Cycle Management. Leads the team for this compound.Responsibilities- Responsible ... engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective- Participates in Global Medical Affairs… more
- BioAgilytix (San Diego, CA)
- …positive relationships that lead to new signed contractsActively manages entire sales life cycle through project engagement and subsequent customer maintenance ... experience with a variety of challenges all while you enable life -changing, life -saving therapeutics to the patients who need them.The Director, Business… more
- ValSource, Inc. (Rahway, NJ)
- …and better control manufacturing processes throughout all stages of the operations life cycle . Full-time employees are offered a competitive compensation package ... in the region as it relates to engaging with new clients in the life sciences sector, and expanding our engagements with existing clients The Project Manager will… more
- Merck & Co. (Rahway, NJ)
- …Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)Experience providing technical and/or programming guidance and ... and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will be responsible in handling day-to-day activities inclusive of life cycle management, issues, deviations, corrections, remediation and improvement ... global biotechnology company dedicated to treating, and one day curing, life -threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced… more
- Merck & Co. (North Wales, PA)
- …conceptsGood working knowledge of reporting processes (SOPs) and software development life - cycle (SDLC)Utilizes and contributes to the development of standard ... and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming… more
- Merck & Co. (North Wales, PA)
- …conceptsGood working knowledge of reporting processes (SOPs) and software development life - cycle (SDLC)Utilizes and contributes to the development of standard ... and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming… more
- Merck & Co. (North Wales, PA)
- …Strong working knowledge of reporting processes (SOPs) and software development life - cycle (SDLC)US and/or worldwide drug or vaccine regulatory application ... and Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming… more
- ValSource, Inc. (Worcester, MA)
- …and better control manufacturing processes throughout all stages of the operations life cycle . Full-time employees are offered a competitive compensation package ... by ValSource for Employee to Family level coverage Basic Life / Short- and Long-Term Disability / Voluntary ...Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages ValSource 401(k) Plan ValSource… more
- ValSource, Inc. (Durham, NC)
- …and better control manufacturing processes throughout all stages of the operations life cycle . Full-time employees are offered a competitive compensation package ... by ValSource for Employee to Family level coverage Basic Life / Short- and Long-Term Disability / Voluntary ...Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages ValSource 401(k) Plan ValSource… more
- Insmed Incorporated (NJ)
- …- Dermatology role will be responsible for supporting the product through its life cycle for hidradenitis suppurativa (HS) via leadership, mentorship, and ... participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insuranceCompany Learning Institute providing access to LinkedIn… more
- Twist BioScience (South San Francisco, CA)
- …that deliver successful productsExperience with building product roadmaps and product life cycle managementExperience with financial modeling and data analysis ... skills. Ability to build and analyze models to forecast and track resultsDegree in molecular biology, genetics or associated scientific field required. Outstanding leadership, teamwork, and communication skillsHands on, high energy, proactive attitude Ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and action plans for identifying and managing risks throughout the product life cycle .Effectively coordinate and manage available resources in developing and ... delivering high-quality safety evaluation related documents/deliverables on time.Coordinate and participate actively in safety-related regulatory interactions (eg, regulatory meetings, post-approval commitments). Qualifications: Successful candidates will be… more
- Merck & Co. (Rahway, NJ)
- …with automation review of equipment specifications, P&IDs, and System Life Cycle documentation-Responsible for troubleshooting challenging equipment/automation ... issues to improve manufacturing performance (eg yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP-Lead automation related investigations into deviations and implement the corrective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Sr Director.Leads medical readiness activities for market launches and life cycle management for select indications/projects. Gains strategic and ... planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for select indications.Serve as medical lead… more
- Eisai, Inc (Baltimore, MD)
- …biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the ... statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and… more
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