- Merck & Co. (Rahway, NJ)
- …facility in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
- Invivyd (New Haven, CT)
- …part of making a difference. Be part of Invivyd. Job Title: Senior Manager/ Associate Director , Drug Safety and Pharmacovigilance Operations Position summary: The ... Sr. Manager/ Associate , Drug Safety and Pharmacovigilance Operations encompasses a key...manner. Manage SAE / SUSAR reporting activities for all investigational drugs Maintain oversight to ensure Global clinical trials… more
- Kyowa Kirin North America (Princeton, NJ)
- …offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion Compliance will ... product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form… more
- Sumitomo Pharma (Pierre, SD)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... provide medical safety support for safety signal management throughout product lifecycle including signal detection, signal validation, signal escalation,… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion.… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director or ... strategies for projects in their assigned therapeutic area portfolio. **Responsibilities** The Associate Director will be responsible to: + Develop regulatory… more
- Ascendis Pharma (Princeton, NJ)
- …develop their skills. Job Overview: We have a dynamic opportunity for an Associate Director , Global Strategic Marketing, who will be responsible for supporting ... growth across multiple regions in preparation for the anticipated launch of an investigational treatment. The role requires the ability to work in a fast-paced and… more
- J&J Family of Companies (Titusville, NJ)
- …of America, Titusville, New Jersey, United States of America **Job Description:** ** ASSOCIATE DIRECTOR , STRATEGIC COMMUNICATIONS & LEARNING - VALUE & EVIDENCE ... SCIENTIFIC ENGAGEMENT- IMMUNOLOGY** Johnson & Johnson is currently recruiting for an Associate Director , Strategic Communications & Learning (SC&L), part of the… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
- Merck (Rahway, NJ)
- …facility in Rahway, New Jersey. The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulatory submissions, which require cross-functional interactions for commercial or investigational product (s). Examples include meeting requests, briefing ... packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets. + Critically reviews documents… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The purpose of the Associate Director , Value Stream CAR T Manufacturing role is to manage and provide ... appropriate level of training necessary for CAR-T GMP manufacturing in a multi- product commercial facility. + Is responsible to maintain their Manufacturing Sr.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products. + ... cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products… more
- BeOne Medicines (San Mateo, CA)
- …assigned project to ensure on-time and high-quality global submissions for investigational , market, and post-approval applications. + Develop regulatory strategy and ... identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and primary liaison to FDA concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected ... strength and competitive advantage lie with our people. The Associate Director , US Product CMC...IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These… more
- Seattle Children's (Seattle, WA)
- …as Medical Director of the Clinical Cell Processing Laboratory (CCPL), Associate Director of the Therapeutic Cell Production Core (TCPC), and Assistant ... TCPC is the Seattle Children's Research Institute's research cell therapy laboratory. The Associate Medical Director is responsible for working with the TCPC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Global Clinical Supply Chain** is a leader who ... for clinical developmental portfolio and ensure on time delivery of investigational medicinal product (IMP) to initiate and resupply clinical studies (eg, GCSC… more
- Fresenius Medical Center (Baton Rouge, LA)
- …+ Ensures appropriate storage, access, and maintenance of records pertaining to investigational product + Conducts routine assessments to evaluate the ... Continues to display a mastery of Senior Clinical Research Associate duties and responsibilities + Adheres to Standard Operating...subject'sresponse to and adherence to investigational product orders, and communicates observations/results to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification preferred ** Associate Director Experience Requirements:** + Two (2) years of ... assigned development projects and US marketed products, the US Product Group RA, US RRL role will provide experienced...experience in a scientific, clinical, and/or medical space. **Sr. Associate Director Requirements:** + Five (5) years… more
