- Exela Pharma Sciences, LLC (Lenoir, NC)
- …relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many consultants, ... Quality , Facilities, Engineering to support their initiatives. The Director of Regulatory Affairswill supervise a team.../ biotech / CDMO industry in a fast-paced multi-jurisdictional high- quality regulatory environment At least 5 years… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion...mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a ... effective, and compliant submissions in line with the overall strategy Drive compliance with regulatory guidelines through prompt communication with relevant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… 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 ... execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and… more
- Merck & Co. (Rahway, NJ)
- …Quality Assurance, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices ... Job DescriptionReporting to the Director of Medical Device and Combination Product ...to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.Provide input to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … to new and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance , Cost of Quality , Validation on Time. ... Position SummaryThe Quality Director is the senior leader...efficient conformance to all quality expectations and compliance with all regulatory standards. This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety, Quality , NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient Support ... the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality /Safety Associate Director . Interacts… 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 ... multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (Rahway, NJ)
- …activities.Communicating, and serving as Quality spokesperson, on a variety of Quality or compliance -related issues. Required Experience :Minimum of 5 years ... gaps and proactively leading the resolution of issues affecting quality and efficiency.Interpreting complex regulatory requirements for various audiences,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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 ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and company ... process qualification, packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance, Finance, R&D, Project Management and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional teams in the analysis and redesign of business processes. Ensure compliance with regulatory standards (eg, ICH, FDA, or other industry-specific ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… 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...and report Adverse Events (AEs) and Product Quality Complaints (PQCs)Collaborates with VP/Medical Affairs to ascertain and… more
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