- Merck & Co. (Rahway, NJ)
- …innovative medicine.We are seeking a Growth and Improvement minded Clinical Operations Manager - Regulatory that can help drive our Strategic Operating ... They are a Competitive Advantage for UsSummary, Focus and PurposeThe Clinical Operations Manager - Regulatory is accountable for achievement and compliance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving..."self-service" for metrics accessibility (eg, report for upcoming planned submissions )Communicate findings and recommendations to key stakeholders through effective,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Insmed Incorporated (Bridgewater, NJ)
- … Operations will be responsible for functional activities related to US/Ex-US regulatory submissions . In addition, this individual will be responsible for ... documents in the Company's electronic document management system (EDMS).ResponsibilitiesRESPONSIBILITIES:Support regulatory submission activities associated with generating electronic submissions… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... following applicable standard operating procedures With limited supervision, lead regulatory writing activities for complex product submissions , including… more
- Merck & Co. (North Wales, PA)
- …contact with regulatory agencies and/or subsidiaries for all applications and submissions . Responsible for regulatory review and final approval for all ... submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single… more
- Merck & Co. (Rahway, NJ)
- …to make decisions independently with limited oversight from Sr.COM or manager .Requires strong understanding of local regulatory environment.Ability to ... for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities include, but… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions . The position will perform validation of the ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Aequor (Thousand Oaks, CA)
- … with a proven track record in the pharmaceutical sector, specifically in regulatory submissions to manage a Regulatory submission transformation initiative ... technology development. Enterprise level engagement. Job Title: Senior Project Manager - End to End Regulatory Content...Senior Project Manager - End to End Regulatory Content Automation Initiative, Global Regulatory Affairs… more
- DivIHN Integration Inc (Lake Forest, IL)
- …Lake Forest, IL Duration: 7 Months Description Exempt/Non Exempt: Non exemptYears. Duties: Manager regulatory submissions ot ensure timely regulatory ... Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines. Manager is...with applicable regulatory agency requirements and guidelines. Manager is Insun Ho Start date will be determined… more
- Eisai, Inc (NJ)
- …industry OR equivalent combination of education and experienceExperience writing/reviewing clinical regulatory documents and submissions for own area of study/ ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions . Responsibilities include: review Case Report Form (CRF) ... ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - CTD ... submissions /Others - May support Common Technical Document (CTD) ...Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on time to support drug development processes and global submissions .Responsibilities- Leadership, Direction, and Strategy:Establishes Risk Based Data Monitoring and ... Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Serve as a lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions . This position may propose strategies for external ... data services they provide to support drug development processes and global submissions . This position provides expertise within Data Management by partnering with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission and inspection readiness for the respective GPTs and related submissions . Facilitate respective regulatory inspection preparation, management and ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure in… more
- DivIHN Integration Inc (North Chicago, IL)
- …analyze submission numbers and various metrics. RESPONSIBILITIES Major Responsibilities: Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF and ... dossiers, submission, progress reports, deficiencies, amendments, etc Support teams to develop regulatory submissions strategy and update strategy based upon … more
- Lennar Homes (Schaumburg, IL)
- …of diversity within our workforce to drive innovation & sustainable growth. Entitlements Manager Lennar is seeking an Entitlements Manager who will be ... and documents in coordination with the land acquisition team for green folder submissions . Meet with City, Count, and Federal agencies to identify and resolve due… more
- Nesco Resource (Southington, CT)
- …scope, timeline, or business goals or the program. Familiar with FDA and MDR regulatory submissions and activities that lead to successful outcomes. Show history ... Position Summary The Program Manager for Infusion Consumables R&D department for the Vascular Access, Sharps safety and Pain Management business units. The Program … more
- Creative Financial Staffing (Indianapolis, IN)
- …Tax Exempts, and more. Supervise the oversight of quarterly and annual regulatory compliance, tax preparation, submissions , and disclosures. Ensure timely and ... who need it. They are searching for a Tax Manager to join their group at their home office...their group at their home office in Indianapolis. Tax Manager Job Responsibilities: Support owners and business entities with… more
