- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… more
- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare compliance ... is preferred A minimum of eight (8) years combined pharmaceutical, human resources, legal, regulatory , and compliance experience required OR a minimum of six (6)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... financial milestones and related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …site, region, and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... role.Expertise in Prelude software or similar dedicated data management applications.Comprehensive understanding of regulatory regulations and company… 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...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Tris Pharma (Monmouth Junction, NJ)
- … compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information ... opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is...data and information to ensure highest ethical standards and compliance with law, regulations, guidelines and policies Assists VP,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …against contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management : Demonstrate ... marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Merck & Co. (Rahway, NJ)
- …transformation that reflects the evolving demands of our business. Risk Management :-Proactively identify potential technical, operational, and regulatory ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient ... maximize your potential with us? The Position The Associate Director will be the lead who is responsible for...and platform support). Essential Functions Partners with PSS Program Management team to ensure vendor compliance with… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination… more
