- Insmed Incorporated (NJ)
- …global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to ... global cross-functional project teams throughout product development and submission activities. The GRL will serve as the global regulatory lead for documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure alignment and execution of global initiatives. The incumbent will oversee the development and promotion of the 6th Mid-Term Strategy for Global QA, ... areas centered around rare diseases and immune disorders. SummaryDirector, Global QA Strategy &Operations (Global R&D PV QA) is responsible for providing strategic… more
- Insmed Incorporated (NJ)
- …Commercial, and Procurement.Shape and implement a global people and capability development strategy for Tech Ops.Oversee cross-Tech Ops training programs, ... (Tech Ops) organization. This leader drives cross-functional alignment, translates corporate strategy into actionable operational plans, and ensures Tech Ops has the… more
- Insmed Incorporated (NJ)
- …Technical Operations leadership team and contribute significantly to our overall product development strategy .You'll lead both drug substance (API) and drug ... the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Small Molecules, to help us expand what's possible for patients… more
- Bayer (Myerstown, PA)
- Packaging Development Scientist IV At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger ... minds to make a real difference, there’s only one choice. Packaging Development Scientist IV The incumbent is responsible for supporting day-to-day the Packaging… more
- Formation Bio (New York, NY)
- …and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs ... cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new...regulatory dossiers. Due-Diligence Support: As part of Formation Bio's strategy to in-license programs and develop to point of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of a global External Scientific Collaboration (ESC) strategy in partnership with Medical and Cross-Functional Partners (Medical, Development , ... ensuring ESC objectives are aligned and embedded in evidence generation, medical strategy , and clinical development plans, where appropriate. Gains strategic and… more
- Merck & Co. (Rahway, NJ)
- …organization. - The candidate will work with regional and local teams to support development and implementation of a sourcing strategy at a global level, ... and lead cross-functional teams through the sourcing process and to provide strategy oversight for regional and/or local components of the category. Day-to-day… more
- Genmab (NJ)
- …of complex, global feasibility initiatives and ability to influence clinical development strategy .Track record of cross-functional leadership in matrixed ... forecasting, and operational risk analysis.Serve as a senior strategic partner to Development Operations (DevOps), Clinical Strategy and external partners to… more
- Merck & Co. (North Wales, PA)
- …are not limited to: Leadership - As a procurement leader, participates in development and implementation of business strategy and ensures delivery of required ... is expected as part of our Company's global procurement strategy .- Our Sourcing team partner with the business to...Director will take an active role in team leadership, development of procurement strategies and interfacing with key and… more
- Bayer (Whippany, NJ)
- …multiple treatment indications and/or multiple programs;Develop the overall early clinical development strategy of radiotracer assets with a central ... contribute to Business Development & Licensing (BD&L) activities;Lead the development and execution of the clinical strategy for diagnostic… more
- Merck & Co. (Rahway, NJ)
- …legal functions.Responsibilities Include But Are Not Limited To:Working independently through product development teams to devise a patenting strategy with the ... sciences inventions.-The position will support programs in all phases of development , from discovery through development and commercialization, and allows… more
- Merck & Co. (North Wales, PA)
- …address any quality issues as needed.The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical ... development programs, using a risk-based approach.The incumbent will be...risk-based approach.The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as… more
- Genmab (NJ)
- …Affairs leadership team responsible for the execution of the US Medical Affairs strategy in support of the US business objectives. The Director, HEOL Team Lead ... in the field, providing the HEOLs with an individualized view of their development plans and ongoing performance. This is a remote position (field-based). Domestic… more
- Eisai, Inc (Nutley, NJ)
- …management in both CTD format and non-CTD format.Experience of the Drug Development process and working with cross functional international /global project ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Insmed Incorporated (NJ)
- …plan for the future to ensure readiness and effectiveness of the team. Strategy Development -Partner across medical affairs and cross-functionally to develop ... strategy relating to IME and External Research to fill...but not limited to medical and regulatory affairs, drug development , FDA and regulatory guidelines (ie, PhRMA guidelines, OIG,… more
- Insmed Incorporated (NJ)
- …for implementing the safety and risk management activities for clinical development ; be responsible for safety surveillance, risk management, and risk communication ... for assigned development products; perform medical assessment of individual adverse event...CTAs).Work with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, ... team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.Responsibilities:Lead the core… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, ... anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs projects within a specific compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy and execution ... generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with GMA… more
