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regulatory affairs in Chicago

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  1. New Indications Medical Director - Gastroenterology - Chicago, IL

    Shall provide guidance to "New Indication" projects for previously approved therapeutic entity including: *** Collaboratively identifying and proving new indication opportunities. *** Developing of new clinical studies. *** Gathering guidance and building advanced product support with healthcare organizations, payors, government entities and key opinion leaders. *** Reviewing and translating data and study results. *** Communicating clinical data, health economics and outcomes research data ...

  2. Gastroenterology - Medical Director - Medical Affairs - Wheaton, IL

    Work closely with marketing and development teams to develop product strategy and ensure delivery of solid medical plans. Shall: *** Gather guidance from healthcare organizations, government entities and key opinion leaders to advise medical planning. *** Manage regulatory and safety issues. *** Support development of a strategic publication plans. *** Ensure that medical strategies reflect stakeholder needs. *** Develop and strengthen partnerships among key stakeholders. *** Design and ...

  3. Medical Officer

    ~~RESPONSIBILITIES 1. Project Assignments • Medical Officer is qualified to exercise the responsibilities of a medical monitor, safety officer, or protocol physician in projects where medical monitoring is a contract deliverable 2. Medical Affairs • Primary or secondary contact for the customer and the sponsor (if not the same entity) for all project-specific medical issues • Primary contact for the project team for all project-specific medical issues • Primary contact for investigative sites for ...

  4. Medical Advisor (Nationwide)

    Our client is seeking a Medical Advisor II that will provide medical and scientific support to both internal team members and external healthcare decision makers and respond to information inquiries. The Medical Advisor will provide scientific support to the commercial activities, research, marketing, and report safety issues within the region consistent with legal and regulatory requirements.   Responsibilities: •Develop and manage relationship with Thought Leaders through scientific exchange ...

  5. Quality Assurance Manager

    Whether you’re just beginning your career or taking your next step toward greater achievements, Smiths Medical offers the global resources, impressive growth and commitment to innovation you need to realize your ambition.   Smiths Medical is seeking a Quality Manager for their Gary, Indiana facility who will be responsible for implementation of QMS process improvement efforts throughout Hardware manufacturing. In addition the QA Manager is responsible to maintain, supervise and control all ...

  6. Medical Advisor (MSL)

    Medical Advisor Work from Home Job Description Medical Advisor II provides medical and scientific support to both internal team members and external healthcare decision makers and respond to information enquiries. The Medical Advisor will provide scientific support to the commercial activities, research, marketing, and report safety issues within the region consistent with legal and regulatory requirements. Essential Responsibilities •Develop and manage relationship with Thought Leaders through ...

  7. Director Regulatory Affairs CMC hh

    Director, Regulatory Affairs CMC Chicago- Description Primary Function • Lead a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers • Key internal leader and driver of regulatory policy and strategy • Influence the development of regulations and guidance • Provide executive management with meaningful regulatory measurements and regulatory opinion • Partner with outside regulatory agencies and trade ...

  8. Senior Director hh

    Senior Director, Regulatory Affairs, Area & Affiliates US & Canada Description Primary Job Function: The function of a Senior Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has division and corporate level influence and is generally considered a key opinion ...

  9. Sr. Director, Regulatory & Quality

    A biopharmaceutical company is actively seeking a Sr. Director, Regulatory & Quality to join their team. This is a full-time permanent position and must be office-based in Chicago, IL.  Candidates must possess the following experience:  Experience with Drug, Pharma, Device, Quality, US, Global experience (ideal candidate will have all of this) Drug experience is absolutely required 8+ years of increasingly responsible regulatory experience  Deep and broad knowledge of regulatory affairs ...

  10. Validation Scientist

    Validation Scientist / Engineer II Position Purpose: Designs, schedules, and executes scientifically and statistically sound qualification/validation experiments which demonstrate that manufacturing Equipment, Facilities, Utilities, Systems, and Processes are in compliance with regulatory requirements, product license restrictions, and industry guidance. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. ...

  11. Quality Systems Technical Writer

    Motivated, savvy quality systems technical writer with extensive experience writing/updating business process documentation, standard operating procedures (SOP), and work instructions.  Can serve as an active voice for quality systems in project meetings as well as cultivate on-going, relationship with the business, quality and IT communities.  Open communicator with a collaborative, proactive approach to problem-solving and issue resolution.  Self-starter with proven leadership ability to utilize ...

  12. Director Regulatory Affairs, US/Canada

    Director  Regulatory Affairs, US/Canada Therapeutic Areas: (2) Oncology, (1) Immunology Location: Chicago Area PRIMARY JOB FUNCTION: Candidate will be responsible for contributing to and implementing strategies to support assigned projects within Therapeutic Area. CORE JOB RESPONSIBILITIES: • Review, compile, and submit variations, new applications, supplements and amendments, as well as responses to Health Authorities as needed • Development, defense, and implementation of robust Regulatory ...

  13. Director Regulatory Affairs CMC hh

    Director, Regulatory Affairs CMC Chicago Description Primary Function • Lead a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers • Key internal leader and driver of regulatory policy and strategy • Influence the development of regulations and guidance • Provide executive management with meaningful regulatory measurements and regulatory opinion • Partner with outside regulatory agencies and trade ...

  14. Vice President of Global Regulatory Affairs

    NW Recruiters is seeking a Vice President of Global Regulatory Affairs. This role will be responsible for assisting in analyzing public policy developments, drafting responses to public policy, legislative and regulatory initiatives.​ Analyze regulatory frameworks in jurisdictions where the firm is or is considering carrying on business, preparing presentations relating to public policy, developing and operationalizing the firm’s South American strategy.​   Responsibilities Deepen the firm’s ...

  15. ~~Regional Clinical Research Associates needed (Central Region)

    Job Description A highly reputable & distinguished corporation is currently looking for Regional Clinical Research Associates needed (location)   Job Description • Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (60% travel with 75% at peak times) for GCP compliance according to company SOPs and/or client guidelines • Recruit investigators for participation in clinical trials • Negotiate study budgets with investigators • Obtain, review for appropriateness, and ...

  16. Medical Affairs and Credentialing Manager

    Medical Affairs and Credentialing Manager Our community hospital currently has an opportunity for an experienced professional in Medical Affairs and Credentialing Manager. This highly visible role plans, develops, organizes and oversees the operations of the medical staff office to meet the requirements of the medical staff bylaws, Joint Commission standards and other applicable federal, state and local regulatory and accrediting agencies. They assist Medical Staff leadership with meeting ...

  17. Sales Manager - Medical Device

    Manager - Medical Devices Industry innovator in leading development and production of medical devices seeks a Business Development - Sr. Product Manager to help lead marketing efforts for the company. The Account Manager will report to VP of Marketing and will work closely with Engineering, Sales, Clinical, Customer Advocacy, Quality Assurance, Operations and Regulatory Affairs personnel. Additionally, The Account Manager will: •Develop and maintain marketing plans, product road maps and ...

  18. Interim Sourcing Manager, Freight and Contracts (4884)

    Position Overview Our client, a multi-billion global pharmaceutical company, seeks an interim manager to oversee transportation of finished goods for its North American and export operations.  Scope of responsibilities will include carrier selection, contract negotiation and management, carrier regulatory compliance, oversight of freight execution for controlled substances, and related issue resolution.  Scope will also include development of a balanced scorecard of metrics and targets regarding ...