- 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
- 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
- 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
- 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
- Santander Holdings USA Inc (Dallas, TX)
- Technology Risk/ Program Management, Sr Associate Country: United States of America Your Journey Starts Here: Santander is a global leader and innovator in the ... We Want to Talk to You! The Difference You Make: The Senior Associate , Technology Risk Management within the Technology and Information Risk Management organization… more
- ICL (Brooklyn, NY)
- …and peer support each day to individuals living with severe mental illness. The Associate program director is a professional and administrative position with ... causes undue hardship to the agency.) Partners with the Program Director to lead and oversee all...for audits and ensure adherence to OMH and other regulatory guidelines. Assist in recruiting, training, and evaluating staff.… more
- Nurix (San Francisco, CA)
- …a new script to outmatch disease. Responsibilities and Duties: The Senior Manager/ Associate Director of Clinical Quality Assurance Auditor is responsible for ... partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR and internal… more
- Revolution Medicines (Redwood City, CA)
- …and experienced technology leader to join the Information Sciences (IS) team as Associate Director , Commercial & Medical Omnichannel Systems. In this role, you ... Excellence Teams). Ensure alignment between field, digital, data, legal, and regulatory teams to support compliant customer journeys and content orchestration.… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …/Neurological Diseases. Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external ... and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K).… more
- Cytokinetics (South San Francisco, CA)
- …individuals who are driven to make a positive impact. Job purpose As the Associate Director of Toxicology, you will play a critical role in advancing ... preclinical guidance to project teams and senior management to inform key program decisions and clinical/ regulatory strategies Oversee contracts, budgets and CRO… more
- Ferring Pharmaceuticals (Parsippany, NJ)
- …ensuring all legal, regulatory and pharmacovigilance requirements are being met. Associate Director will also interact regularly with brand teams and other ... stand up to the world's oldest enemy: disease. The Associate Director , Patient Access will manage day...program business rules and all safety, legal and regulatory requirement. Collaborate with vendor to update business rules… more
- Vantive (Deerfield, IL)
- …mission to extend lives and expand possibilities. Your Role at Vantive As the Associate Director , Head of Safety Operations, Safety Systems and Data Management , ... operations, including- Literature, Quality Control, Clinical case processing- and regulatory compliance of North America according to PV regulations....for PV Safety Systems and Data Management. As the Associate Director , you will be part of… more
- Xaira Therapeutics (Brisbane, CA)
- …and London. About the Role We are seeking a highly skilled and proactive Associate Director , Research Project Manager to oversee the planning and execution of ... our South San Francisco, CA office five days per week. Key Responsibilities Program Leadership, Planning & Execution Serve as the primary project manager for… more
