- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (North Wales, PA)
- …and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must ... Reporting into Product Line Lead Patient Safety and Quality & Compliance , this position will be responsible for managing the development and implementation of… more
- Merck & Co. (North Wales, PA)
- …results, providing guidance to the team on strategic prioritiesCollaborate with Legal, Regulatory , Compliance , and the CAT during review processPartner with ... Job DescriptionTitle: Associate Director, Product Marketing Owner - Scientific Strategy and Payer Access Team Lead, Heart FailureGeneral Description: Our commercial… more
- Merck & Co. (North Wales, PA)
- Job DescriptionDirector, Legal - US Commercial and Compliance LegalWe partner with the business to ensure we maintain our company's values and high ethical ... fraud and abuse risks. -The position also provides legal support to the Compliance department on various matters. -The role provides legal counseling services that… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Process & Product Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and ... tools for drug substance (upstream, downstream, and conjugation) and drug product manufacturing unit operations using a variety of process-modeling tools.-As a… more
- Merck & Co. (Rahway, NJ)
- … product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other ... Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled,… more
- Merck & Co. (Rahway, NJ)
- …chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements.6. Foster a culture of excellence, ... portfolio.-3. Collaborate with cross-functional partners, including R&D, Quality, Regulatory , Manufacturing, Technical Product Leaders, and Value Chain… more
- Merck & Co. (Durham, NC)
- …actively participates in project suite teams, as required.Direct support of regulatory inspections and audits.Direct support of validation activities and all other ... Change Control.Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.-Is expected to possess a high degree of problem-solving… more
- Merck & Co. (Durham, NC)
- …will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include ... and new product license registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirementsInfluence, motivate, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Merck & Co. (Durham, NC)
- …and new product license registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirementsInfluence, motivate, and ... Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety)Collaborate with site compliance team to ... responsibility. IMPACT: InfluenceRepresents Quality in the laboratory to influence cGMP compliance and ensure product quality.Explains difficult issues and… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval ... Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops,...products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Merck & Co. (Rahway, NJ)
- …and Skills: -The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process ... strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product … more
