- Insmed Incorporated (Westerville, OH)
- …for authentic and experienced Therapeutic Specialists with demonstrated success in new product launches who are committed to our mission to transform the lives ... current rare disease market. Maintain exceptional knowledge of: disease state, product , customer, orphan/rare and specialty drug market, competitive landscape and… more
- Catalent (St. Petersburg, FL)
- Manager, QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations,… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product life cycle. Collaborates ... Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product life cycle.Develops… more
- Merck & Co. (Rahway, NJ)
- …candidate for the position of Senior Principal Scientist (R6) within the Biologics product development group. Primary duties: Be a seasoned biologics product ... sterile products for injectable, ophthalmic, and inhaled routes of administration. Support both early and late-stage development candidates that will include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one ... data science techniques under the minimal supervision of a group leader; studies support the aligned strategy (defined in the Evidence Generation Plan - EGP)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Merck & Co. (Durham, NC)
- …This individual must actively manage his/her team to reliably support customer demand (including employee development, routine coaching sessions, recognition, ... site procedures to resolve process/equipment issues, minimize downtime, and ensure product quality.- This role actively supports, participates, and embraces an… more
- Merck & Co. (Rahway, NJ)
- …(EIT) is an essential component of the current IT division that provides support to the Pharmaceutical Research, Supply Chain, Marketing organizations as well as ... the associated enterprise assets, and cost-effective delivery of capabilities to support achievement of immediate and future state business objectives.This Sr.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …accounting, uphold workplace safety, manage our supply chain and sampling, support technology, provide commercial operations, insights & analytics, maintain our ... be the Master Data Management (MDM) primary Subject Matter Expert (SME) for Market Access and Public Affairs (MAPA),...the Manager for Data Stewards of Patient, Customer and Product masters. Role will also be responsible for day-to-day… more
- Lundbeck (Bothell, WA)
- …October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration ... Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation...and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a thorough… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management tools and resources.Responsibilities- Strategic Advice and Support to Global Product Teams: 1) Provides expert , strategic advice on the creation ... defined by leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk… more
- Tris Pharma (Monmouth Junction, NJ)
- …in each other and in respectful, open and honest communications to help support individual and team success.We have an immediate opening in our Monmouth Junction, ... conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality Assurance (QA),… more
- Novo Nordisk Inc. (WA)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one ... and internal/external partners. Essential Functions Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical… more
- Taiho Oncology (New York, NY)
- …The role of the Sr. MSL is non-promotional in nature. Performance Objectives: Product /Therapeutic Area Support to External Stakeholders: Acts as the primary ... specified geography for information about the disease state and Taiho's product (s) and compounds to ensure awareness and understanding. Provides high-quality… more
- Eisai, Inc (Raleigh, NC)
- …you. Essential Functions Accountable for the oversight of onsite activities to support packaging equipment projects and initiatives related to primary and secondary ... improvements and/or equipment enhancements, including cleaning verifications/validations and provide support / troubleshooting during investigations related to packaging or… more
- Merck & Co. (Rahway, NJ)
- …Brochures before release from our company to external agencies and investigators.Provide expert advice to Product Development Teams and subsidiaries on ... and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within… more
- Catalent (Philadelphia, PA)
- …reviewing and approving batch records, and releasing batch records and finished product . They will have a deep understanding and values around patient and ... network. Packaging can be configured to hold a single product or multiple products as determined by study requirements....collectively with the QADC team.Act as site subject matter expert for "Good Manufacturing Practices" and SOPs related to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are ... to make a difference?The Position The Director, Medical Writing is an expert in medical writing and performs work independently with minimal-to-no supervision. The… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people.This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. ... process improvements.Responsibilities may include but are not limited to: Support operations production through start-up and commissioning and qualification through… more
