- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, an Associate Principal Scientist /Associate Director, has primary responsibility for planning/managing real world and ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist /Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Eli Lilly and Company (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral ... strategies and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory… more
- L'Oreal (Clark, NJ)
- …partners (CROs/external vendors, global Advanced Research, Applied Research, Safety and Regulatory Affairs , Technology Incubators, and skin and hair care ... Position Title: Associate PrincipalClinical Research Scientist , Open Clinical Innovation Advanced Research,L'Oral Research & Innovation Location: Clark, New Jersey… more
- VA Oklahoma City Health Care System (Oklahoma City, OK)
- …Oklahoma City VA Health Care System is recruiting one Supervisory Clinical Laboratory Scientist (Laboratory Manager) to help care for our Veterans as part of ... methods, program changes or conflicts between scientific/technological requirements and regulatory or program requirements. Provides the full range of supervisory… more
- Syneos Health Careers (Morrisville, NC)
- Description Clinical Scientist (EMEA, NA, LATAM) - Sponsor - dedicated Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built ... to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical… more
- Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT)
- …Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs , Patient Safety and Pharmacovigilance to implement ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- …will be essential *Interact with scientists, medical directors, and Technical Operations / Regulatory Affairs personnel for the timely completion of clinical ... our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and...will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) ... for the assigned portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals and organizational initiatives, on an… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA CMC-Parenteral Commercial Products to be a part of the Lilly ... tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and … more
- Merck (Upper Gwynedd, PA)
- … issues to GRACS CMC management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Lilly (Indianapolis, IN)
- …all over the world. The Sr. Principal Scientist **or** Advisor Post Approval Scientist in Global Regulatory Affairs - CMC Commercial Products will ... regulatory strategies and submissions for Lilly's commercial products. The scientist will be expected to leverage innovative regulatory strategies that… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will ... regulatory strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate innovative regulatory… more
- Veterans Affairs, Veterans Health Administration (Miami, FL)
- …Clinical Laboratory Scientist : vacareers.va.gov/wp-content/uploads/sites/5/Total-Rewards-of-a-Medical-Technologist-Career-Flyer.pdf The ... The CLS maintains all certifications required of a clinical laboratory scientist . Applies knowledge of compliance requirements for laboratory functions. In addition… more
- Hologic (Marlborough, MA)
- …to support product positioning and market expansion. + Collaborate with R&D, Regulatory Affairs , and Marketing to integrate clinical strategies into product ... Clinical Scientist , R&D, Clinical Affairs Marlborough, MA,...working cross-functionally to generate high-quality clinical evidence that supports regulatory clearance, market adoption, and business growth. **Key Responsibilities:**… more
