- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced...and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the drug development process with thorough ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... effective and statistically sound CAPA plans and issue resolution.The Senior Director will ensure stewards have the appropriate processes and playbooks, appropriate… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral ... and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Clinical Director (Distinguished Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical development, including determination… more
- Merck & Co. (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, ... Job Description Director -QP2-IO We are seeking an experienced talented...the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics… more
- Merck & Co. (Rahway, NJ)
- …(BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP ... Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of… more
- Merck & Co. (Rahway, NJ)
- Job Description Overview: The Director , Global Media Relations, is responsible for developing and executing a global media strategy that showcases our Company's ... development, product approvals, thought leadership, policy, and overall performance. The director will build and maintain strong working relationships with pharma,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information ... stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial...and will be onsite 60% of the timeReporting StructureThe Director Information Security will report directly to the VP… 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 (NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible for the oversight of Clinical ... of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management consistency across… more
