- Merck & Co. (Rahway, NJ)
- …problems, support pilot plant operations, and interface with cross-functional colleagues/customers in drug substance, drug product , and material science. ... crystallization, moving from laboratory to pilot plant or production scale.Experience with drug product processing and experience collaborating across the … more
- Genmab (Plainsboro, NJ)
- …to an innovative and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional ... cross-functional and global franchise leadership meetings, escalating critical issues to senior leadership.Collaborate with the SVP to manage US Oncology Leadership… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, ... laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early..., Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization. Relationships The Director -Patient Centered Outcomes Research reports directly to a Senior Director within the CDSE RWE team. This is a US ... data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and ... contract manufactured products. The Director plays a leadership role in interactions with the...the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently… more
- Genmab (Plainsboro, NJ)
- …fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Merck & Co. (Rahway, NJ)
- …or Biotech industry.Experience in planning and execution of strategies for drug or vaccine product registration, commercialization and life-cycle management ... development and project management within biopharma and other science-based product innovation industries to bring innovation, external perspectives, new ideas,… more
- Merck & Co. (Rahway, NJ)
- …strategy that aligns with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to supply.- Talent ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization... development, commercialization, and supply, including comprehensive knowledge of drug substance (DS), drug product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications and BLA annual reports. Collaborate with all disciplines ... for regulatory filings.Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... and execution of an integrated product development plan. This position is accountable for partnering...Global Team leader as the Project Management lead on drug development projects. This position can be assigned to… more
- Merck & Co. (Rahway, NJ)
- …functional impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting ... team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral… more
- Merck & Co. (Rahway, NJ)
- …accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s).-Works directly in the SAP system ... visible forecast for all products used within the assigned program(s) (ie Bulk Drug Product ).--Oversees all bulk drug supply management and ensures… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that ... ability to travel over 50 %.Head, Medical Science Liaisons (MSLs) / Director , Medical Training, Pain therapeutic space is responsible for field leadership of… more
- Genmab (Plainsboro, NJ)
- … Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide ... development, regulatory, commercial, and market access teams to incorporate insights into product strategies and to support product launches and lifecycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... Senior CMC Lead regarding the activity status and potential...drive strategies and activities for early and late phase drug development candidates within the team to support overall… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... areas regarding clinical issues related to oncology compounds.-The Executive Director /PDT lead may:-Manage Directors and/or Senior Directors responsible… more
- Merck & Co. (Rahway, NJ)
- …affairs, statistics, and manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving… more
- Merck & Co. (Rahway, NJ)
- …Attributes and Quality by Design principles, and advanced data analysis for drug development applications.-The Director selects, trains, and effectively works ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...will be responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.… more
