- Merck & Co. (Rahway, NJ)
- …Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... of new compounds, and the further study of marketed compounds.Support of business development assessments of external opportunitiesThe Senior Director May:… more
- Merck & Co. (Rahway, NJ)
- …be the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel to discuss projects, ... long-standing or significant issues affecting quality and efficiency.Interprets complex regulatory requirements for various audiences, reviews draft policies and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... ingredients (API), biologics, vaccine drug substances and finished products. As Director , you will support Quality audits and health authority inspections and… more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- …to transform drug delivery and manufacturing technology to positively impact patients.The Director of Oral Formulation Sciences will lead a team of scientists and ... by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionCurrently we are looking for an Associate Director Packaging Engineer. Welcome to the teamOur Packaging Technical Operations (PTO) team is where we ... critical flaws.Experience and knowledge of the pharmaceutical environment including regulatory requirements.Familiarity with application of Lean Six Sigma principles,… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Merck & Co. (Rahway, NJ)
- …in the laboratories, and for always maintaining a state of inspection readiness.- The Director should be well engaged with regulatory and industry trends and ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing and ensure safety and quality of our products. -The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for providing ... of candidates from the discovery interface, through first product registration.- -The Director will be responsible for a team of approximately 10-15 scientists and… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Merck & Co. (Rahway, NJ)
- …unique and complex problems specific to the brands within the team. Anticipating Business and Regulatory Needs: Anticipating internal and external business ... Job DescriptionThe Director , Global Scientific and Value Content-Healthcare Professional (Dir...organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work… more
- Merck & Co. (Rahway, NJ)
- …key Commercial stakeholders.- Responsibilities include influencing, managing and prioritizing business requirements to ensure supply in the 0-to-36-month horizon.- ... includes determining short and mid-term needs, managing aspects of the integrated business planning process, supporting the 5 Year Plan and Assumptions Based Review… more
- Merck & Co. (Rahway, NJ)
- …reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In ... by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not… more
- Merck & Co. (Rahway, NJ)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Merck & Co. (Rahway, NJ)
- …help people around the globe. We are currently recruiting for Associate Director , US MarketingThe role will oversee foundational strategy and planning, including ... drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an Agile operating model… more
- Eisai, Inc (Nutley, NJ)
- …the development of regulatory strategies to ensure effective achievement of regulatory / business objectives. The Executive Director will direct the ... this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global … more
