- AbbVie (North Chicago, IL)
- …objectives, both strategic and applicable regulatory requirements. Director , Safety , Regulatory and Medical Affairs Quality Standards is responsible ... for the management of a RDQA global Safety , Regulatory Affairs (RA) and...role reports to the Senior Director of Safety , Vigilance and Medical Affairs Quality Assurance.… more
- AbbVie (Mettawa, IL)
- …and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation… more
- AbbVie (North Chicago, IL)
- …Medical Affairs Quality Assurance is responsible for the management of a RDQA global Safety , Regulatory Affairs (RA) and Medical Affairs (MA) QA team ... post market vigilance and post market studies, assures patient safety , maintains data integrity, fosters regulatory compliance,...role reports to the Senior Director of Safety , Vigilance and Medical Affairs Quality Assurance.… more
- Lundbeck (Deerfield, IL)
- Director Medical Affairs Psychiatry - Remote Opportunity Requisition ID: 5094 Location: Deerfield, Illinois, US Do you want to join a team where the mission is ... anywhere in the greater United States** **SUMMARY:** The Medical Director , Medical Affairs will serve as one...the pharmacovigilance group (may serve as member of the safety committee) regulatory documents and interactions +… more
- AbbVie (Mettawa, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Scientific Director , Medical Affairs - Dermatology provides specialist medical and ... scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical… more
- AbbVie (Mettawa, IL)
- …activities with internal stakeholders (eg, commercial, clinical operations, market access, regulatory ) as they relate to on-going medical affairs projects. ... in terms of compelling content, multichannel communication, deployment of digital medical affairs tactics and the importance of legal, regulatory and compliance… more
- AbbVie (Mettawa, IL)
- …product safety and risk management plans. May also carry responsibility for safety monitoring reports to regulatory agencies. May review, assess and report ... with those requirements. Serves as the scientific team interface for key regulatory discussions. Drives medical affairs activities and generation and… more
- AbbVie (Mettawa, IL)
- …medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, ... (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).… more
- AbbVie (North Chicago, IL)
- …drug, device and cosmetic portfolio. The role reports to a Director of Safety , Vigilance and Medical Affairs Quality Assurance. There is an expectation that ... medical device/nutritional or related industry. Four years in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to… more
- Lundbeck (Deerfield, IL)
- …- Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the ... Director US Regulatory Global Strategic Labelling...development programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling… more
- Lactalis American Group Inc. (Chicago, IL)
- Director , US Health & Safety Chicago,...trends, challenges, and solutions in the areas of health, safety , regulatory affairs , case law ... IL (http://maps.google.com/maps?q=540+West+Madison+Street+Chicago+IL+USA+60661) * Manufacturing Job Type Full-time Description TITLE: Director , US Health & Safety REPORTING TO:VP… more
- AbbVie (North Chicago, IL)
- …+ Interacts with and influences other cross functional departments (eg Clinical Development, Regulatory Affairs , Medical Affairs ), as needed, to ensure the ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Executive Medical Director is responsible for the safety strategy for Hematology… more
- AbbVie (North Chicago, IL)
- …supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and ... strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA… more
- AbbVie (North Chicago, IL)
- …lifecycle. . Maintain clear communication channels with key stakeholders and partners (Development, Safety , Regulatory Affairs , HEOR, Medical Affairs , ... the direction of the Oncology Therapeutic Area (TA) Head in Global Epidemiology, the Director serves as the Epidemiology Asset Strategy Lead for one or more assets… more
- AbbVie (North Chicago, IL)
- …the product lifecycle. + Collaborate with key stakeholders and cross-functional partners (Development, Safety , Regulatory Affairs , HEOR, Medical Affairs , ... the direction of the Immunology Therapeutic Area (TA) Head in Global Epidemiology, the Director serves as the Epidemiology Asset Strategy Lead for one or more assets… more
- AbbVie (North Chicago, IL)
- …physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical Writing. Safety ... statistician to serve in a leadership role in our Safety Statistics team. The Director , Safety...study SAPs, ISS SAP). + Provide strategic input on safety related submissions to regulatory agencies and… more
- AbbVie (North Chicago, IL)
- …clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to ... and drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety , or GMA) to create development strategies for… more
- AbbVie (North Chicago, IL)
- …and drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety , or GMA) to create development strategies for ... development experts Statistical programmers Data science experts Global Medical Affairs experts Regulatory experts Additional Information Applicable only… more
- CSL Plasma (Chicago, IL)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). **Job...approval to resume donating. + Assures the health and safety of donors participating in the non-red blood cell… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Medical Director leads the direction, planning, execution, and interpretation of clinical ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.… more