- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... 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)
- …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...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for an Associate Director , US Oncology Marketing Hematology. We are seeking a highly motivated and experienced ... for the promotion of a hematology product. This position will report to the Director and Commercial Marketing, who is part of the US Hematology Marketing Team.The… more
- Genmab (Plainsboro, NJ)
- …oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned ... assess the impact on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for… more
- Merck & Co. (North Wales, PA)
- …innovative medicines that help people with cancer across the globe.The Regional Associate Director of Medical Affairs - Gastrointestinal Cancer (RADMA) position ... with the Upper GI and Lower GI US Regional Director of Medical Affairs (RDMAs) and partner with regional...and Skills: Experience with US healthcare treatment guidelines and regulatory process - Experience working in the pharmaceutical industry,… 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 ... clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …valued as we work together to change lives for the better. The Position The Associate Director , Digital Content Strategy & Production reports to the Dir, Content ... Social Media Marketing and related recommendations for the NNI US website. The Associate Director supports the development and evolution of NNI's content… 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 ... Qualification)Support our company's Animal Health sites in their preparation for Regulatory Agency Inspections by conducting audits, "Mock Inspections", training and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionJob Description:The Associate Director , Marketing, HPV Scientific Strategy plays a critical role in supporting the HPV vaccine franchise.- The HPV ... opportunities.Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), Center for Observational and Real-world… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are seeking an experienced, strategic, and results-oriented- Associate Director , Partnership Management-to support and drive our internal and ... roles and process, and will maintain the highest level of compliance with regulatory requirements, and applicable laws and regulations. In addition, we are seeking a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… 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...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Tris Pharma (Monmouth Junction, NJ)
- …Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , ... Associate Director / Director , Analytical Research...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project… 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
