- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions… 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
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director … more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the ... ensuring the highest standards of scientific integrity, patient safety, regulatory compliance, and collaboration across therapeutic areas. Ultimately, this position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... will drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global Oncology I&A Team and partners closely with Market… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Associate Director of US Medical Affairs Hematology Strategy will report to the ... Director , US Medical Affairs Hematology Strategy Lead. S/he will...collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We have a hybrid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect ... the analysis and redesign of business processes. Ensure compliance with regulatory standards (eg, ICH, FDA, or other industry-specific requirements). Conduct regular… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… more
- Merck & Co. (Rahway, NJ)
- …areas and routes of administration, including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of ... Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... and other related topics for all clinical supplies across all assigned program ( s ) . - Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in the… more
- Merck & Co. (Rahway, NJ)
- …(eg GxP) Understanding of pharmacovigilance-related IT systems, data and gateways/interfaces with regulatory bodies such as the EMA and FDA Proven ability to bridge ... the gap between business requirements and technical systems Excellent communication skills, both written and verbal Preferred experience and skills: Demonstrated ability to develop and implement strategies and manage a portfolio of projects Knowledge of Agile… more
- Genmab (Plainsboro, NJ)
- …experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsExperience with operational management and budget ... planningProven performance in earlier role/comparable roleGlobal clinical program level experience requiredExperience within the field of oncology is preferredMinimum 2 years' experience as Clinical Operations representative in Clinical Development Teams… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor ... Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely and ... accurate delivery of payroll services and is responsible for maintaining the payroll system and related technologies.ResponsibilitiesManages all payroll supporting processes and controls which include:Provides audit support for internal and external auditors.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology ... area preferred TravelAbility to travel up to 30% Global and domestic travel. International collaboration and communication (face to face, electronic and tele/video conferencing) across all global time zones required Daiichi Sankyo, Inc. is an equal… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Director in the CCFS group and working in conjunction...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
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