- Merck & Co. (Rahway, NJ)
- … Affairs practices. The SRO is a recognized internal management consulting team within Medical Operations, driving strategic, large-scale, cross-functional ... SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently met.Facilitate the creation and approval… more
- Novo Nordisk Inc. (Chicago, IL)
- …such as digital health, academic training programs, and Professional Associations/Public Affairs /Policy initiatives Work with Program Development and Training to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...analytic support to the field team, and assists the Program Development and Training function for the TA. SD… 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
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support...to the development and functioning of the crisis/ issue management program . Ensure product safety issues and… more
- Arthrex (Naples, FL)
- …medical education in orthopedics. Arthrex is actively searching for a Sr. Project Manager, Program Manager - Regulatory Affairs who is responsible for ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs . Develops project objectives by reviewing project proposals… more
- Catalent (San Diego, CA)
- …Quality Management Reviews, etc. and oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This ... process. Site Change Control/ change management programs. Site Risk Management . Site Supplier Management Program .In-process QA activities, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Market Research. The position has high exposure to senior management and requires a highly motivated individual who is...data for purposes of assessing market access trends, hub program utilization, and performance against defined KPIs Function as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include working with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs , Regulatory Affairs and other NNI skill areas. External ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific input to Marketing/Market Access departments as needed Project management liaison: Assist in developing clinical program … more
- American Honda Motor Co Inc (Torrance, CA)
- …join our team to Bring the Future!Job PurposeThe Department Lead, Environmental Regulatory Affairs manages PRO's environmental regulatory compliance strategy ... interpretations for both existing and new/nascent business areas. Working with the Regulatory Affairs Division Lead, this position will help represent Honda to… more
- Merck & Co. (Rahway, NJ)
- …requires proven strong project management skills and/or project management certification or relevant training program /close mentoring. Position ... This role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with ICH/GCP and country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program . Evaluates CMC changes for portfolio biologics and ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Novo Nordisk Inc. (San Francisco, CA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between… more
- Lundbeck (MA)
- …staffing for specific products or initiatives Collaborate with Medical Affairs colleagues (Medical Directors, Medical Excellence, Clinical Development, Global ... of the neurology therapeutic space, clinical research processes, and regulatory guidelines Strong interpersonal skills with demonstrated excellence and success… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... a minimum of 4 years pharmaceutical experience in brand management /marketing in the biotechnology/pharmaceutical industryExperience in HCP personal and non-personal… more
- The University of Vermont Health Network (Burlington, VT)
- … Regulatory Affairs assists with the implementation of the organizations regulatory program to assure that an effective and comprehensive regulatory ... skills-Ability to work with all levels of staff and management -Previous experience with JC/ regulatory agency preparation, coordination, education… more
- DivIHN Integration Inc (Chicago, IL)
- …development, case report form development, contract negotiation, site recruitment, support program management for project reviews, budget and timeline ... Years Experience Level. Looking for 1-3 years of medical affairs management experience. MD required Must be...to give input on clinical trials. Meet with the regulatory team About us: DivIHN, the 'IT Asset Performance… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …follow-up and management , tracking, trending and reporting of Complaint Program management and activities. Manage complaint investigations with support from ... cross-functional teams, and communicate directly with customers. Responsible for CAPA program management and oversight, including but not limited to initiation,… more
