- Merck & Co. (Rahway, NJ)
- …Affairs, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory ... Job Description Associate Director , Regulatory Submissions Archive Operations -...and implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director , Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team.- The individual ... to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Brief Description of Duties: Under the supervision of the City Administrator, the Director of Community Development is an exempt position under FLSA. Ensuring that ... independent judgement and simultaneously considering the financial, ethical, legal and regulatory variables that affect the City is vital. Performs complex and… more
- Insmed Incorporated (NJ)
- …requires a blend of technical expertise and business acumen to ensure regulatory compliance , system integrity, and alignment with business objectives across ... as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications, while also functioning as… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currenting recruiting for a qualified Compliance and Legal Director to join our team. The role reports to the Managing Director and ... The role has a global collaborative outreach and the Compliance and Legal Director will be part...have the following qualifications: A Bachelor's degree in law, regulatory affairs, pharmacy, or related field. A legal practicing… more
- Eisai, Inc (Nutley, NJ)
- …performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ... with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages ... your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the...and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and alignment with… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical ... authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or Site Quality Head… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Merck & Co. (Rahway, NJ)
- …Name Development, Process Improvements, Professional Presentation, Project Management, Regulatory Compliance , Strategic PlanningPreferred Skills: Current ... the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are...for these launches, we are looking for an Associate Director (AD) to join our center of excellence.Description:-Under the… more
- Eisai, Inc (Dallas, TX)
- …If this is your profile, we want to hear from you. The Associate Director , Access and Reimbursement (AD ARM) will lead the Eisai Access and Reimbursement Managers ... Access and Reimbursement Services, Sales, Marketing, Government Affairs, Legal, Compliance , Medical, and Training. Ultimately, this individual will be responsible… more
- Merck & Co. (North Wales, PA)
- …Program Marketing across the Immunology portfolio.- This position will report to the Director , US Marketing Patient Support.- The Associate Director will shape ... stakeholder to define go-to-market plans for the PSP. - The Associate Director , US Marketing, Patient Support Strategy & Effectiveness is responsible for shaping… more
- Merck & Co. (Rahway, NJ)
- …Project Management Information Systems (PMIS), Project Planning, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement {+ ... Office (PMO); and Administrative Professionals. Position Description/Summary: The GPAM Associate Director , Value & Implementation Project Manager (VIPM), is a core… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, ... publishing and document management within Veeva Submissions Vault, ensuring accuracy, compliance , and timely delivery of submissions to regulatory agencies.What… more
- Formation Bio (New York, NY)
- …vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... Evidence (RWE) Capabilities & Analytics team is looking for an Associate Director , Data Strategy & Partnerships with expertise in data strategy, advanced analytics,… more
- Repligen (Waltham, MA)
- …our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role in aligning technology ... implement, and optimize technology solutions that enhance operational performance and compliance . The ideal candidate brings deep knowledge of the bioprocessing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead, Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) organization, ... documents that govern activities and updates/ revises in collaboration with legal and compliance , to drive agility and innovation as we develop and enhance ways of… more
