- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical ... Regulatory Affairs Operations with Labeling Process and/or Digital Enablement...soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS… more
- Merck & Co. (Rahway, NJ)
- …- Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other ... development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as the… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... Team representative as an Analytical Lead for a drug program .Key Responsibilities:Responsibilities include developing and optimizing analytical methods using… more
- Merck & Co. (San Francisco, CA)
- …component of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an... Associate Director will work with scientists within… more
- Merck & Co. (North Wales, PA)
- …operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance). Responsible for ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Eisai, Inc (Exton, PA)
- …as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… 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, ... Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... Director in Biologics Cell Culture Sciences group and working...will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our ... contribution Tuition reimbursement, the Freedom 2 Save student debt program , and FreeU education benefit - an affordable and...RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory … more
- Prescient Healthcare Group (Boston, MA)
- Director / Associate Prinicpal Medical and Scientific Strategy Consulting Who Are Prescient? We are a specialist, strategic partner to global biopharma companies. ... and innovation through strategic thinking. What role will I play on projects? As a Director / Associate Principal, you will act as a strategic partner to our… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …defining the next generation of pharmaceutical access in a high-growth environment. The Associate Director , Managed Care Payer Contracting plays a pivotal role ... view Draft language that reflects negotiated terms and ensures legal and regulatory compliance Create and maintain contract templates, playbooks and clause libraries… more
- Kenvue (Summit, NJ)
- Kenvue is currently recruiting for a: Associate Director , Self Care R&D What we do At Kenvue , we realize the extraordinary power of everyday care. Built on over ... organization's strategies and provides appropriate updates to senior management Technical program management and execution for both internal and external development… more
- AbbVie (North Chicago, IL)
- … compliance, and contributes to the overall success of drug/device development programs. Associate Director , Safety, Medical & Regulatory Quality is part ... Regulatory Agency inspections. The role reports to the Director , Safety, Medical & Regulatory Quality. There...consultation to ensure an inclusive and effective R&D audit program . Drive necessary change and efficiency through the provision… more
- Corcept Therapeutics (Redwood City, CA)
- …a fundamental shift in the way we understand and treat disease. The Associate Director , IT Business Relationship Management (BRM) - Compliance will serve ... and IT, enabling the delivery of technology solutions that align with regulatory requirements, business strategy, and operational goals. This role is responsible for… more
- Dyne Therapeutics (Waltham, MA)
- …and follow us on X, LinkedIn and Facebook. Role Summary: The Associate Director , Biostatistics will provide leadership and guidance for assigned ... clinical studies within a clinical development program (s). He/she will be responsible for or contribute to...statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts. The ideal candidate… more
- Insight (Chicago, IL)
- …and Medical Center , located in Chicago, is seeking an experienced and motivated Associate Pharmacy Director . This position will support and assist the Pharmacy ... Director in overseeing operations across specialty, inpatient, outpatient and...the hospital. Ensures the pharmacy is compliant with all regulatory and accrediting standards including 340B program … more
- Altruist (San Francisco, CA)
- …strategies from SaaS and fintech to the custodial platform context-navigating regulatory complexity and advisor-specific workflows. Lead and mentor Sales Ops talent: ... leave Professional growth and development opportunities including an employee mobility program and an annual L&D budget allocation for each employee Physical… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …is true to the best of my knowledge. Job Description About the Role: The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device ... to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. Core Responsibilities: Device Clinical Strategy & Risk Management:… more
