- Merck & Co. (North Wales, PA)
- …solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk -Provide regulatory consultation in the development ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for ... risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that govern the organization's technology… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …commercialization.Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory , and Quality Control ... Job DescriptionThe Associate Director of Method Development & Testing is responsible...(QC) facilities to ensure that functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety ... Physician(s), and cross-functional team in support of benefit risk profile throughout product life cycle. Collaborates with the PSL(s) to proactively plan and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide medical and scientific input to labelling Assist in the interpretation of regulatory guidelines and directives to judge risk and causality Medical and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Merck & Co. (Rahway, NJ)
- …characterization Recruit and develop talent Be proactive in resource planning, risk assessment strategies and budget management as necessary (including merit and ... a strong network internally and across the external academic and regulatory community, advance a culture of scientific excellence, Good Manufacturing Practice… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management, Quality Assurance, Medical Affairs, Translational ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Merck & Co. (Rahway, NJ)
- …risk assessment, control strategy, process comparability reports, and/or regulatory submissions.Adaptability and agility to prioritize and deliver complex ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
