- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain… more
- Merck (Philadelphia, PA)
- …is in regulatory affairs . **Required Experience and Skills:** + Regulatory experience preferred for therapeutic area experience in vaccine or infectious ... **Job Description** The Director, Regulatory Affairs Liaison, is responsible for...their assigned projects in the Vaccines and Infectious Disease therapeutic area. The selected individual will function with a… more
- Novo Nordisk (Princeton, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Novo Nordisk (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... maintains constructive and positive interactions with colleagues. Essential Functions + Therapeutic Area: + Assist Manager /Director in review of labeling for… more
- US Tech Solutions (Horsham, PA)
- …for conducting RWV&E evidence generation and dissemination activities for assigned therapeutic areas, pipeline and marketed products or indications, within the ... Evidence Team (IET), to support the RWV&E strategic plans for the assigned therapeutic areas * Manage research studies, market access analytics & activities and… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can be ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...expert for our products and related data within a Therapeutic Area (Diabetes-GLP-1, Diabetes-Insulins, Cardiorenal Diseases, Obesity, NASH, Rare… more
- Sanofi Group (Trenton, NJ)
- …understanding of the scientific and medical value of our products in the therapeutic area and gather new insights by b** **ringing cutting edge scientific exchange ... + Exhibit a high degree of scientific and clinical knowledge in the therapeutic field to help identify and critically assess research opportunities and to play… more
- J&J Family of Companies (Horsham, PA)
- Manager , Medical Writer Scientific Communications - 2406180830W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager , Medical Writer ... for humanity. Learn more at https://www.jnj.com/. We are recruiting for a Manager , Medical Writer to join the Scientific Communications team, supporting our… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …skills. + Demonstrated understanding of compliance, ethical, legal, and regulatory guidelines impacting the pharmaceutical industry, Medical Affairs , ... true to the best of my knowledge. **Job Description** **About the role:** The Senior Manager US Field Medical Excellence Operations will serve as a key member of the… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Project Manager A Job Profile Title Manager Research Project A Job Description ... Summary The Project Manager will coordinate multiple efforts. This includes clinical coordinating...Monitoring participant health and safety throughout the study. + Regulatory Compliance and Study Planning and Preparation: Assisting in… more
- Sanofi Group (Trenton, NJ)
- …understanding of the scientific and medical value of our products in the therapeutic area and gather new insights by bringing cutting edge scientific exchange today ... our products. + Keep abreast of medical and scientific developments in the therapeutic field to help identify and critically assess research opportunities and to… more
- Sanofi Group (Trenton, NJ)
- …Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' ... with external stakeholders to enhance the understanding of the therapeutic area and medical value of our products. +...plans. + Co-create/develop Country Medical Plans (with TA Medical Manager , Medical Director or MSL Head) and lead team… more
- University of Pennsylvania (Philadelphia, PA)
- …sponsors. This position will report directly to the Lead nurse and team manager and work directly with Physician Investigators ("PI") on clinical research performed. ... subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating… more
- University of Pennsylvania (Philadelphia, PA)
- …recruitment, detailed data entry, subject visits and follow-up and regulatory documentation. Position contingent upon funding. Job Description Responsibilities + ... monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the … more
- University of Pennsylvania (Philadelphia, PA)
- …The Clinical Research Coordinator B (CRC-B) will report directly to a Project Manager within the 2-PREVENT Breast Cancer Translational Center of Excellence (TCE) and ... will focus on coordinating non- therapeutic longitudinal and observational protocols. The CRC-B will have...monitoring visits and audits, 5) Assist the TCE Project Manager , Program Director, and/or PI with preparing materials for… more
- University of Pennsylvania (Philadelphia, PA)
- …individual will work under general supervision. Assist CTT program manager with initiating study procedures for new industry-sponsored and investigator-initiated ... internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the supervisor.… more
- University of Pennsylvania (Philadelphia, PA)
- …purpose of this position is to coordinate essential industry sponsored therapeutic trials in patients with early-onset neurodegenerative conditions such as ... will additionally maintain ISF, including DOA log and other sponsor specific regulatory logs; record and distribution of meeting minutes under supervision of Project… more