- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle management of GCO Risks and ... (design RM oversight tools, management, and maintenance), and provide day-to-day operational risk support to study teams and their line management to ensure… more
- Merck & Co. (North Wales, PA)
- …solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk -Provide regulatory consultation in the development ... in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life ... guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation… more
- Merck & Co. (Rahway, NJ)
- …comprehensive understanding of global regulatory expectations and contribute to regulatory documents and interactions with agencies. The Associate Director ... in West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding immunology pipeline.As an Associate … more
- Novo Nordisk Inc. (Stamford, CT)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research… more
- Merck & Co. (Rahway, NJ)
- …the CTCs, CRAs and COMs).Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF and other ... HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Associate Director, Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and Value ... management and vendor partnersPossesses a strong understanding of relevant regulatory guidelines and compliance requirements pertaining to Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology,… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Merck & Co. (Rahway, NJ)
- …drug products.Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile and ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Build deep fundamental knowledge around the drug product… more
- Merck & Co. (Rahway, NJ)
- …the Director Marketing Parasiticides within our Companion Animal Business Unit.The Associate Director will have primary responsibility to grow brand recommendation ... annual marketing mix analysis for brand planningWork collaboratively with legal, regulatory , and scientific partners on development and approval of marketing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director, US Oncology - Hematology Scientific Strategy. This talented individual will lead ... verbal communication skills.Experienced in bringing promotional materials through legal, regulatory , and medical review.Requires approximately 20% travel, including some… more
- Insmed Incorporated (San Diego, CA)
- …lists.OverviewReporting to the Executive Director of Program Management, the Associate Director, Program Management supports the cross-functional drug development ... in accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead...teams and ad hoc project team meetings Conducts the risk management and scenario planning and develops contingency and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Durham, NC)
- …hands-on training Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ability to work both independently and as ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
