- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Formation Bio (New York, NY)
- …multiple categories, including software, contract research organizations (CROs), contract manufacturing organizations (CMOs), and other drug development ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Merck & Co. (Rahway, NJ)
- …with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract ... Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and… more
- Genmab (NJ)
- …you join us!The RoleAre you ready to make a meaningful impact in oncology drug development and be part of a dynamic, collaborative team that values innovation, ... Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role… more
- Tris Pharma (Monmouth Junction, NJ)
- …to develop and implement procurement strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance with… more
- Genmab (NJ)
- …are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above ... other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related to data… more
- Insmed Incorporated (San Diego, CA)
- …including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert knowledge of scale-up principles with respect to viral ... and procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions.Must be familiar with BSL-II lab safety requirements.Participate in… more
- Merck & Co. (Durham, NC)
- …seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing development and… more
- Organon (Plymouth Meeting, PA)
- …and Commercial to embed an adaptable process with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies ... Job Description The Position The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory ...and medical leave, and health benefits including medical, prescription drug , dental, and vision coverage in accordance with the… more
- ProPharma Group (Western Springs, IL)
- …the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical ... solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Essential Functions: Draft high-quality, complex contracts,… more
- Sanofi (Morristown, NJ)
- Clinical Science Operations Engineer - VIE Contract Location: United States of America, Morristown Target start date: 01/11/2025 iMove, the Sanofi VIE Program, is ... us? Be part of a pioneering biopharma company where patient insights shape drug development. Work at the forefront of AI-powered science that accelerates discovery… more
- Emprise Bank (Wichita, KS)
- …contract management strategies aligned with organizational goals and regulatory requirements. Advise stakeholders on contractual risks, structuring, and ... extraordinary customer experience to help our customers achieve their goals. The Contract Management position plays a pivotal role in managing high-value, complex… more
- Red River Communications (Abercrombie, ND)
- …Prepare financial models and analysis to support capital investments, pricing, contract negotiations and strategic initiatives Monitor company cash flow and ... financial regulations Prepare and submit financial data and reports to regulatory bodies Coordinate and support annual audits Lead investment portfolio strategy,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …view Draft language that reflects negotiated terms and ensures legal and regulatory compliance Create and maintain contract templates, playbooks and clause ... payers, PBMs, and other market access stakeholders. This position ensures contract strategy aligns with organizational goals and compliance standards, facilitating… more
- LEESAR INC (Fort Myers, FL)
- …guidance from stakeholders. Ensure compliance with contractual obligations and regulatory requirements. Monitor contract performance including key performance ... opportunities by empowering healthcare systems to achieve optimal performance. Every contract signed and every new process implemented reflects our dedication to… more
- Vivo HealthStaff (Berkeley, CA)
- …regulations. The ideal candidate will have a strong background in healthcare law, contract review, and regulatory compliance, with specific experience in the ... Provide legal analysis and guidance on 340B program compliance, including eligibility, contract pharmacy arrangements, and regulatory changes. - Review, draft,… more
- Abbott (Lake Forest, IL)
- …with the approved protocol. Ensures compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance ... communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements. Verification that the investigator is enrolling only eligible… more
