- 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 ... in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director....including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Affairs interests on cross-functional teams including, Field Medical Affairs , Medical Operations, Clinical Trial Management, HEOR, Market Access, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Medical Affairs Postdoctoral Fellowship is a one-year, experiential program based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external stakeholders. Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs , medical affairs , legal, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...make a difference? The Position Supports the North America Clinical Development (NACD) Clinical Research Equity (CRE)… 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 ... difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis...sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and Market ... Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical Affairs point to identify investigators/sites and… 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 ... cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , market access and policy/advocacy (MAPA), and channel leads to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, Clinical Trial Management, and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Penn Medicine (Plainsboro, NJ)
- …shape our future each day. Are you living your life's work? The Regulatory Affairs Manager is responsible to assist with organization-wide readiness. The ... this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today...Manager will assist the organization to maintain compliance with… more
- Novo Nordisk (Plainsboro, NJ)
- …documents to FDA. Relationships The fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific ... regulatory guidance documents. Demonstrate efficient handling of compliance tasks. Assist specialists and colleagues in regulatory assessment of compliance tasks + Support preparations for interactions with global regulatory authorities (eg, meetings, IR… more
- Novo Nordisk (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 ... in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director....including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and… more
- Bristol Myers Squibb (Princeton, NJ)
- …policies. Conduct monthly reconciliation of business expenses. + Ensure manager 's preparedness for meetings, including assembling meeting materials, assisting with ... and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability,… more
- Merck (Trenton, NJ)
- …Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of ... GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed… more
- Taiho Oncology (Princeton, NJ)
- … Affairs standard operating policies & procedures and Medical Review operations. The Manager will be working with the Medical Affairs and matrix teams on ... continuous process improvement projects, Medical Affairs platforms and Medical Affairs standard operating policies and procedures. The manager will perform… more
- J&J Family of Companies (Titusville, NJ)
- Manager , Medical Information - Payer and Health Systems - Titusville, NJ - 2406220999W **Description** Johnson & Johnson Innovative Medicine (JJIM) is recruiting for ... a Manager , Medical Information, Payer and Health Systems to be...formulary requests, and custom requests working collaboratively with Medical Affairs and Real-World Value & Evidence (RW V&E) therapeutic… more
- Novo Nordisk (Plainsboro, NJ)
- … Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and Market ... Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical Affairs point to identify investigators/sites and… more
- J&J Family of Companies (Titusville, NJ)
- …across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality, and speed in the ... Regulatory Program Manager , Immunology (1 of 2) - 2406218581W **Description**...Lead the operational execution of select marketing applications including, clinical variations and Pediatric submissions, partnering to ensure alignment… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Product Manager Date: Nov 4, 2024 Req ID: 3692 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: TIS Embolotherapy Terumo Medical ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- Edwards Lifesciences (Trenton, NJ)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience… more
