- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to...regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global… more
- Tris Pharma (Monmouth Junction, NJ)
- …help support individual and team success.We have an immediate opening for a Head , Medical Science Liaisons (MSLs) / Director, Medical Training for our Pain division. ... This is a field-based position that requires ability to travel over 50 %. Head , Medical Science Liaisons (MSLs) / Director, Medical Training, Pain therapeutic space… 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)
- …living. Are you ready to make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and… more
- Merck & Co. (Millsboro, DE)
- …and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head /Director of Quality . They will be responsible for ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Merck & Co. (Rahway, NJ)
- …external service activities to ensure supply continuity that meets our quality , compliance, and regulatory standards.Strategic collaboration with Procurement and ... in accordance with US and WW regulations, company policies and standard operating procedures.The head of GCS External Partnership & Sourcing is a core member of GCS… more
- Cambrex High Point (Charles City, IA)
- Job Overview The Director, Quality and Regulatory Compliance will support regulatory activities related to Chemistry and Manufacturing (CMC) as well as the ... direction, support and advice for our CDMO organization. The Director, Quality and Regulatory Compliance will be responsible for engaging with internal and… more
- Astellas Pharma (Northbrook, IL)
- …Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose:** As a very senior SRS member, this position is part of the SRS LT or part of ... methodologies use. The position represents Astellas in interfaces with regulatory agencies globally, chair sessions in international statistics meetings, leads… more
- Frontier Medicines (South San Francisco, CA)
- …and budget to support all development candidates + .Work collaboratively with Quality Assurance and Regulatory to review analytical documents, stability results, ... seeking a highly motivated individual for a newly created Director/ Senior Director role in Process Chemistry in either Frontier's...manufacturing batch records and regulatory documents pertaining to drug substance and approve as… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory trends for CMC activities, to ensure robust and high- quality regulatory filings in all major countries + Develop, implement and execute ... and documentation systems + Strong knowledge of ICH and other regulatory guidelines including Quality by Design + Maintain an active understanding of the future… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems + Contribute to product development from Research to Commercialization ... global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads +...line and function heads + Lead global CMC and Quality key initiatives and represent Pharm Sci to other… more
- West Pharmaceutical Services (Tempe, AZ)
- Sr . Quality Manager Requisition ID: 66480 Date:...with US and other regional/ country legislation, act as Head of Quality Control/ Head of ... initiatives which possess global impact. + Reporting to the Sr . Director, Quality Assurance, the role will... KPIs and communicate it to the organization and senior management. + Responsible and accountable for quality… more
- AbbVie (North Chicago, IL)
- …requirements. 6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & ... with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP). Qualifications… more
- Citigroup (Irving, TX)
- The Risk Policy Senior Officer I is a strategic professional who closely follows latest trends in own field and adapts them for application within own job and the ... communication skills required in order to negotiate internally, often at a senior level. Developed communication and diplomacy skills are required in order to… more
- ThermoFisher Scientific (San Francisco, CA)
- …to the Head of Cell Therapy Quality , a subgroup within the Quality Unit. The Sr Quality Control Specialist oversees the Technology Transfer of ... QC Analytical, collaborates closely with supervisors, line management, clients, and ( senior ) scientists from Process Development (PD) and QA. Develops and empowers… more
- MUFG (New York, NY)
- …of our recruitment team will provide more details. **Job Summary:** As a Sr Relationship Manager (" Sr .RM") for Financial Institutions Group "FIG", he/she is ... the objectives of the Bank and the Division. The Sr RM, who is mainly responsible for FIG credit...Primary Offices and other relevant parties in providing high quality overall banking services to the clients. Maintain regular… more
- TD Bank (Philadelphia, PA)
- …of Business:** Business Management, Strategy & Support **Job Description:** The Sr Business Mgmt Specialist leads a significant business management function and/or ... requiring broad managerial and deep specialized knowledge at the enterprise, business, regulatory and industry levels + Undertakes and completes a variety of complex… more
- Citigroup (Fort Lauderdale, FL)
- The Senior Portfolio Credit Risk Manager is a senior management-level position responsible for managing a Citi Global Wealth credit portfolio within an assigned ... skills required in order to negotiate and influence, often at a senior level. Some external communication/negotiation may be necessary. Accountable for end results… more
- ThermoFisher Scientific (Wilmington, NC)
- …extensive experience working on clinical trials in Cardiovascular indications.** ** Sr Oversight Director, Project Management** At Thermo Fisher Scientific, you'll ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
