- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Cambridge Health Alliance (Cambridge, MA)
- …Patient Safety, and working collaboratively with Quality and Safety leadership, the Manager , Accreditation & Regulatory Compliance leads efforts to ensure ... and Center for Medicare and Medicaid Services. In this role the Manager , Accreditation & Regulatory Compliance proactively plans, implements, coordinates and… more
- Aequor (Thousand Oaks, CA)
- …on time. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to ... functions.Responsibilities:Lead medium/small projects independently and work directly with Program Manager on large multi-year programs. Managing the overall program… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the ... process by applying the appropriate measures (writing of code, review of code/deliverable).Supports submissions by ensuring programming deliverables are consistent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Position Title: Senior Biostatistician Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... solve complex study problems.Responsibilities:Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …system rejections or missing/incomplete data daily- Analyze various payment files; calculate, review , verify and post a variety of complex payroll data such as ... Analyze files submitted for completeness, audit updates to the payroll register, review state tax information for accuracy and appropriate processing, and establish… more
- Aequor (West Greenwich, RI)
- Feedback from Hiring Manager intake call: What location will this role be tied to? 100% remote role, preference is eastern time zone. But EM is open to other time ... role? Role supports quality management systems, office based, EW will be supporting recall regulatory reporting 50% of their time and other projects for the QMS team… more
- Novo Nordisk Inc. (Boulder, CO)
- …dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is ... Regulatory , Quality Control, Supply Chain, and Clinical Write, review , and/or approve Standard Operating Procedures, specifications, regulatory filings,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... Identify opportunities for improvement within the customer campaigns and engagement. Review and interpret campaign/tactic data to inform adjustments on customer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently and for review , approval, and use ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Merck & Co. (Millsboro, DE)
- …our systems such as Reliance, Atlas SRM, WorkDay, myLearning, eTime, Inspire.Compose, review , edit institutional SOPs.Serve as the hiring manager and trainer ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Aequor (Thousand Oaks, CA)
- …Deviations / CAPA process - Build and present quality records summaries for Senior Management review . Provide timely and comprehensive process and status updates ... experience managing in Track Wise or Veeva Systems Have quality experience manager records Project management skillsThe Specialist Manufacturing is expected to own… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** ** Senior Manager , US Medical Ad/Promo Regulatory Review ** **Takeda Pharmaceutical** **Lexington, ... or Exton, PA** **About the role:** Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on… more
- Publicis Groupe (New York, NY)
- …clients) follow the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a key role in establishing ... stability and experience of a global leader. **Overview** The Senior Manager , Regulatory Promotional Operations...advising on specific projects to aid smooth and fast review by clients. The Senior Manager… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Writing and Quality Review professionals support the authoring and quality review for a variety of clinical and regulatory documents. We are ... a global, dynamic, and diverse team residing within Global Regulatory Affairs. We work collaboratively to advance the strategy...evaluate document review scope and estimate required review time. Escalates to more senior team… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Manager , Regulatory CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... from immunological diseases. Position Summary: Vera is seeking a Senior Manager , Regulatory CMC to...optimal implementation of changes. * Establish and implement internal regulatory processes, author and review SOPs and… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Regulatory Operations and Publishing Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology ... Regulatory Operations and GXP Information Systems, the Senior Manager , Regulatory Operations and...management, PDF publishing and review , eCTD Publishing, review and archiving consistent with global regulatory … more
- Publicis Groupe (New York, NY)
- …startup company with the stability and experience of a global leader. **Overview** The Senior Manager , Regulatory Promotional Operations, is a subject matter ... materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. Acting as a lead for a... review process from start to finish. The Senior Manager provides expert guidance on submission… more
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