- Merck & Co. (North Wales, PA)
- …the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... Review (OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose creative, effective,… more
- Merck & Co. (North Wales, PA)
- … success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... regulatory leadership as needed in product in-license/due diligence review , product divestment and product withdrawal.Support new technology development.Demonstrate… 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
- Merck & Co. (North Wales, PA)
- …Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.Participates in regulatory due ... Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for...approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct reports. Review ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Review and interpret regulatory guidelinesContinuing ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other appropriate groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review and interpret ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or provide information/data for regulatory filings.May serve as the single regulatory representative on study teams. Review and interpret regulatory ... 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)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance ... and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of building, leading and ... Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.RolePerform safety review of Adverse Event reports for Genmab products. Perform ongoing surveillance ... departments and ensure appropriate and timely handling of safety issues. Provide safety review and input to various documents including but not limited to: Trial… more
- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in ... study start up (eg, database set up) Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the… more
- Merck & Co. (Rahway, NJ)
- …aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job ... contactors, and external business partnersPerform and Support PV audits as required. Review and Approve Corrective and Preventive Actions (CAPA)s which are necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV)...the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we work together to change lives for the better. The Position The Associate Director , Digital Content Strategy & Production reports to the Dir, Content & Channel ... Media Marketing and related recommendations for the NNI US website. The Associate Director supports the development and evolution of NNI's content strategy in close… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... Vice President, Human Health and Manufacturing Communications, the Executive Director , Vaccines Communications is responsible for the development of strategic… more
