- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leading a high performing, cross-functional global project team composed of representative of asset through the lifecycle from research to post-marketing ... design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, market acesss and… more
- Merck & Co. (Boston, MA)
- …Associate Principal Scientist to contribute to our company's protein therapeutic drug discovery and early clinical development efforts. -This position will be ... The ideal candidate will lead PDMB efforts as a project-team representative and PK/PD subject matter expert, regularly interacting with multi-disciplinary discovery… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish and ensure deliverables to/from Data Monitoring Committees (DMCs) Is safety representative in Trial Squad: Plan, execute and drive all activities related ... to safety and ensure coordination with other project deliverables Is safety representative in cross functional project teams as needed eg Global Project Team (GPT)… more
- Merck & Co. (North Wales, PA)
- …coordinates, and provides biostatistical leadership and support for related drug /vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory, ... trials, and in coordinating the statistical activities for clinical drug /vaccine projects.May interact with Academic Research Organization (ARO), Contract Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible ... of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product, or New Modality)...functional experts as needed. Participate as site launch team representative in the CMC working group meetings, as needed,… more
- Catalent (Manassas, VA)
- …critical thinking skills.The work environment characteristics described here are representative of those an employee encounters while performing the essential ... work environment is usually moderate.The physical demands described here are representative of those an employee encounters while performing the essential functions… more
- Merck & Co. (Rahway, NJ)
- …part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology ... to registration.Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of … more
- Insmed Incorporated (Bridgewater, NJ)
- …our headquarters facility in Bridgewater, New Jersey.ResponsibilitiesResponsibilitiesAdditional representative responsibilities will include, but not necessarily be ... limited to, the following: Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical ... studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug . This position effectively works independently for all phases of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.Participate in global project team meetings (development and/or ... information/data for regulatory filings.May serve as the single regulatory representative on study teams.Review and interpret regulatory guidelines. Continuing… more
- Taiho Oncology (TX)
- …and OK Position Summary: The Medical Science Liaison (MSL) is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage ... as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and align the… more
- Catalent (Manassas, VA)
- …is a plusWork Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential ... categoriesCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000… more
- Catalent (St. Petersburg, FL)
- …to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may ... ProcessesCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in this role will also act as the US Reg Intel & Policy regional representative , directly responsible for Reg Intel & Policy activities focused on the USA, alongside ... and a working knowledge of global regulations and guidelines regarding drug development (incl. CMC), regulatory submissions and corresponding regulatory agency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PV inspections in alignment with regulatory and company strategy.Act as the management representative for all key health authority inspections (US FDA, EU EMEA, MHRA ... government and local agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+ years of Strong… more
- Taiho Oncology (New York, NY)
- …Summary: The Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage ... as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Uses medical affairs plans to develop and align the… more
- Catalent (St. Petersburg, FL)
- …internal technical departments. This position is expected to serve as a representative for Catalent's strategic clients as well as support the clients with ... of PTOCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving… more
- Catalent (St. Petersburg, FL)
- …St. Petersburg's customers and internal organizations. This position serves as a representative for their clients within the Catalent St. Petersburg site. The QA ... Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving… more
- Insmed Incorporated (Bridgewater, NJ)
- …activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable for all ... that drive process standardization and simplification across the company.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited… more
- Commonwealth of Pennsylvania (PA)
- Drug & Alcohol Program Representative (Local Government) - Allegheny County D&A (Multiple Vacancies) Print ... (https://www.governmentjobs.com/careers/pabureau/jobs/newprint/4536682) Apply Drug & Alcohol Program Representative (Local Government) - Allegheny County D&A… more
