- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a ... Job DescriptionThe Associate Director - Device Tech Transfer is...technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners,and Technical Product Leaders, regulatory and quality.Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance considerations into research planning and execution across all phases of drug development Develop and maintain Patient Safety onboarding and ... a strategic leader for the role of GxP Patient Safety , Compliance & Vendor Oversight within our Clinical, Medical...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a ... Job DescriptionJob Summary: -The Associate Director of Device Technology is...global and site-specific projects related to combination products and drug delivery systems.Ensure that all activities are conducted with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based ... in Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic...and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that the manufacturing… more
- Merck & Co. (Rahway, NJ)
- …as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness ... overall success of the pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the successful candidate will be an… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Clinical Research Scientist will support and work predominately with ... monitoring and safety oversight activities.Work with medical monitors and drug safety to provide support and scientific review of adverse events and related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in PV; required7 or More Years Minimum of 7 years of Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; required4 ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... Medical Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse… more
- Merck & Co. (Upper Gwynedd, PA)
- …science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology ... Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for the planning and directing...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Merck & Co. (Boston, MA)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform ... compliant supply of commercialized products for the benefit of patients. The Associate Director of MDCP Platform Packaging and Assembly Technical Leadership… more
- Eisai, Inc (Cincinnati, OH)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with… more
- AbbVie (Chicago, IL)
- …CAPA investigations as necessary Qualifications + MD or equivalent + Associate Medical Director I - Drug safety experience preferred but not required + ... Associate Medical Directo r II - 1 - 2 years drug safety experience with medical assessment/clinical case review required. Additional Information Applicable… more
- University of Colorado (Aurora, CO)
- **Medical Director for the Heart Institute Quality and Patient Safety - Associate Professor** **Description** **University of Colorado Anschutz Medical ... specialty **Condition of Employment:** + Must successfully pass a drug test through Children's Hospital Colorado + _Must be...Director for the Heart Institute Quality and Patient Safety - Associate Professor - 33245 Faculty Provide… more
- Merck (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a ... **Job Description** The Associate Director - Device Tech Transfer is...technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners,and Technical Product Leaders, regulatory and quality.… more
- Boehringer Ingelheim (St. Joseph, MO)
- …tools as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety and efficacy part of the ... such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam… more
- AbbVie (North Chicago, IL)
- …the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and ... to effectively conduct safety surveillance * Conducts safety surveillance for pharmaceutical/biological/ drug -device combined products; contributes to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Therapeutic Product (ATMP) such as oligonucleotides. The Associate Director /Senior Associate Director of EACD for drug product (DP) development, will ... within EACD. The Associate Director /Senior Associate Director of EACD for drug...to EACD. * Ensure compliance with all required training, safety , regulatory, HR, laboratory notebook, intellectual property, GMP's and… more
- Charles River Laboratories (Memphis, TN)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... about. **Job Summary** Acts as the Environmental, Health & Safety subject matter expert responsible for the oversight of...discovered. + Report and work directly with the Site Director with a dotted line to the EHS&S Business… more
- Organon & Co. (Jersey City, NJ)
- …pharmaceutical or biotech industry with extensive and in-depth knowledge of non-clinical safety assessment and drug development, including a strong background in ... **Job Description** **The** **Position** The Non-Clinical Safety Assessment Representative within the Non-Clinical Development (NCD) team, is accountable for the… more
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