- 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
- 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. (Rahway, NJ)
- …and CRD as needed.Works in partnership with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary… 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
- Merck & Co. (Washington, DC)
- …Director will monitor, analyze, and communicate internally about federal legislative and regulatory activities and initiatives.- The Associate Director will also ... Job DescriptionPosition Description: Associate Director, Federal Policy and Government Relations The...limited to: Research and provide analysis of federal legislation, regulatory proposals, government data, third party stakeholder activities, and… 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
- Fidelity TalentSource LLC (Boston, MA)
- …part of the Associate and Leadership Communications organization within Corporate Affairs . Working closely with the most senior leaders within the Fidelity ... Job Description:The RoleAs a Senior Communications Manager for Fidelity Wealth, you will...areas of accuracy, ethics, legal, and complianceWorking across Corporate Affairs and with business partners (eg, HR, Strategy &… more
- Sunrise System Inc (Atlanta, GA)
- …(OCMO) Senior Leadership Team Office of the QPPV Global Regulatory Affairs International Pharmacovigilance Leadership Other partners across business Required ... Job Title: Sr. Associate , Aggregate Report Compliance Job ID: 24-02289 Location:...help. Working within the Global Environment / Global Teams Regulatory Affairs experience MAIN ASPECT OF ROLE:… 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
- 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 ... Oversee regulatory support and compliance in accordance with guidelines...in accordance with guidelines from USDA, FDA, and international regulatory agencies. Responsibilities will be related to new product… 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 ... Description: Oversee regulatory support and compliance in accordance with guidelines...in accordance with guidelines from USDA, FDA, and international regulatory agencies. Responsibilities will be related to new product… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC...Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying and ... people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop 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
- Astellas Pharma (Northbrook, IL)
- …should be elevated to upper management for further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that ... promotion review processes are compliant with approved company procedures. Represents Regulatory Affairs in cross-functional initiatives such as committees,… 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
