- Merck & Co. (Rahway, NJ)
- …regulatory affairs.Three (3) years of experience in managing regulatory submissions and document management systems such as Veeva Vault and RIMSStrong knowledge ... individual with a strong background in regulatory affairs and project management to support our cross-functional projects and streamline our regulatory operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead role is an exempt level position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to ... in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and document … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Control Specialist role is an exempt position responsible for supporting the document management process within a cell therapy manufacturing facility to support ... in a sterile GMP environment. This role will ensure compliance within the document management system, document storage & retention, and document issuance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity. The incumbent is responsible for ... diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, ... medical writer with a bachelor's degree in a relevant science field.Submission document writing experience required. Travel: Ability to travel up to 5%… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, ... medical writer with a Bachelor's degree in a relevant science fieldSubmission document writing experience required Travel Ability to travel up to 5%. In-house/remote… more
- Insmed Incorporated (San Diego, CA)
- …processes and analytical laboratory practicesExperience working with an electronic document management system (EDMS)Experience at reviewing procedural documents, ... review, collaboration, and direction for laboratory investigations.Apply Quality Risk Management for key processes and systems. Identify improvement opportunities… more
- BioAgilytix (Durham, NC)
- …educational workshops; review professional publications; establish personal networksAssist in document management activitiesPerform duties with minimal QA ... Management oversightAdditional ResponsibilitiesOther duties as assignedMinimum Preferred Qualifications - EducationBachelor's degree in biology, chemistry, biochemistry, medical technology, or other scientific disciplineNot less than two (2) years'… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Control Supervisor serves as the system owner for the Enterprise Quality Management System (EQMS). Lastly, the Documentation Supervisor shall be responsible for ... initiatives. Job ResponsibilitiesManages the Documentation Control Unit to ensure the following: Document Change Controls (DCCs) are processed in a timely manner,… more
- Merck & Co. (Omaha, NE)
- …to provide accurate information to both internal and external customersUtilize account management tools to document service for future referenceActively listen ... for ensuring customer service needs are met in the organization, coordinating order management activities, and engaging with other areas of our company to address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manifests,and tracking ad hoc shipments in trackers)Review the CRO partner Sample Management Plan, to document cross-functional agreements on the tracking, ... and immune disorders. Job Summary The Biosample Operations Manager, Biosample Management is responsible for supporting the oversight of the end-to-end lifecycle… more
- Merck & Co. (Rahway, NJ)
- …technical architecture team designing digital solutions within the Market Access and Revenue Management (MARM) value team. Our MARM IT team operates as a business ... across the value teamApply the information architecture tool set used to document and manage information architecture assets including data governance.Stay up to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director, Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... diseases and immune disorders. Job Summary: The Director, Development SOP Management is responsible for providing strategic direction, planning, coordination, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Associate Director, Program Management is a senior position responsible for effectively planning, managing, and ... in Daiichi Sankyo (DS). Reporting to the Sr. Director, Enterprise Program Management , this position requires a capable leader with strong technology and business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …And in the R&D space including but not limited to clinical trial management system, drug labeling, and learning management system.Administration of enterprise ... and enterprise scheduler operational issues. Track problems and incidents and document status from team members and communicate status and system performance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to maximize your potential with us? The Position The "Senior Architect - Data Management & AI" is a technical leader with a deep understanding of business goals, ... with architectural standards. Relationships Reports to a member of the IT Management Team. Interacts with internal stakeholders across business units as well as… more
- Tris Pharma (Monmouth Junction, NJ)
- …opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management .Tris Pharma has a long track record of successful alliances, from global ... commercial partnerships to R&D collaborations to manufacturing/distribution partnerships. Alliance Management plays the critical role in establishing and maintaining… more
- Aequor (Thousand Oaks, CA)
- …GxP Governance, will execute required activities to coordinate, prepare, execute and document the execution of GxP Quality Management Reviews. Position ... as needed. SUBMIT CANDIDATES AT MARKET RATE! Ideal candidate: Strong time management skills, multi task and manage multiple projects, executive level communicator.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …GMP documentation management including the routing and approval flow in Document Change Control (DCCs) Reviews local Quality Management System (QMS) ... your career. Are you ready to realize your potential? The Position Executes the document creation & revision process for NNUSBPI standards & other documents in order… more
- Merck & Co. (North Wales, PA)
- …and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market ... that can enhance value and use of our company's products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported… more
