- Aequor (Newbury Park, CA)
- …requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …program and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...& evidence team and other relevant functions As a senior level representative of medical affairs , the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
- Merck & Co. (Rahway, NJ)
- …as needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director… 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 ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… 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 ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... Business Planning & Strategy. The incumbent works closely with associate directors, directors, VPs, and other senior ...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Actalent (Des Moines, IA)
- …trials. * Review, update and draft new Standard Operating Procedures (SOPs) within the Regulatory Affairs Department as needed. * Review and prepare outlines of ... Quality Assurance efforts. * Perform other assigned duties as required. Skills: Regulatory affairs , Regulatory , Pharmaceutical, Document Control, … more
- Invenergy (Denver, CO)
- …We own. We operate. We are Invenergy. Job Description Responsibilities + Collaborate with Regulatory Affairs team members in the West region and across regions, ... as well as other internal departments. + Manage external counsel and consultants. + Build relationships with and lobby external stakeholders including those with leadership positions in CAISO, WECC, FERC, state and regional trade organizations,… more
- AbbVie (Lake Bluff, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - ... with Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation and guidance. +… more
- Boehringer Ingelheim (St. Joseph, MO)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director, Regulatory Affairs Pharma Safety & Efficacy ... you will: Act as Regulatory Affairs (RA) team member in projects...Profile and Quality Target Profile. + Works with more senior RA team members to provide consistent regulatory… more
- Abbott (Abbott Park, IL)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Associate Director of Regulatory Affairs ** **About Abbott** Abbott is ... Lake County, IL currently has an opportunity for an ** Associate Director Manager of Regulatory Affairs...and oral reports to internal and external audiences, including senior management and regulatory agencies. + Negotiate… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior Leadership. **About you: To be successful in this… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- AbbVie (Chicago, IL)
- …or Industry-related experience. + Preferred Experience: 5 years in pharmaceutical regulatory affairs . + Demonstrates effective communication skills in written ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology)… more
- AbbVie (Irvine, CA)
- …the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence ... https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director of Regulatory Innovation supports … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …electronically from FDA. + Perform other duties as required. **Primary responsibilities for the Regulatory Affairs Senior Specialist role:** + Act as ... and other duties as needed. **Primary responsibilities for the Regulatory Affairs Specialist role:** + Manages dossier...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… more
