Manager, Medical Affairs

Job Profile and Summary:

This position will be responsible for management of Medical Safety aspects, defined as Medical Affairs’ (internal and cross-functional) processes related to the evaluation, assessment, and action on events related to medical practices, and Cordis medical products. The candidate will interact with the Cordis Medical Director and Clinicians from the Complaint Handling and Quality Departments in facilitating medical safety evaluations and decisions.

Accountable for implementing the Company’s standard operating procedures, standards of medical safety and care, available evidence and regulatory guidelines in daily decision-making.

Together with the other Clinical Research Managers he/she shares accountability for a continuing progress in process- and SOP development and adaptation to optimally address the changing internal and external environment.  

Essential duties and responsibilities:

  • Partners with Complaint Handling, Safety Vigilance, and Regulatory groups to support appropriate reporting of adverse events to FDA, competent authorities and regulators. Evaluate and investigate of the complaint process. Confirm awareness date for serious injuries.
  • Receive clinical input from QA clinicians and determine reportability of subject codes/product malfunctions, consequence codes, adverse events, probability & likelihood, and assist in the rationale in the Hazards List.
  • Ensure consistent medical evaluation of complaints to determine reportable events.
  • Coordinate complaints received through non-standard channels, such as verbal communications, clinical evaluations, literature and publications, etc.
  • Monitor and consider external patient data that may be directly posted and become accessible in public databases (for example, safety data).
  • Act as a designee (of the Medical Director) in medical safety processes.
  • Establishes and maintains good and effective working relationships with the Company’s Medical Director, clinicians, scientists, core-labs, clinical consultants, and internal clients.
  • Key role in compliance & ethics, maintains good relationships with internal and external compliance partners. Ensures a professional clinical approach which is in compliance with highest ethical and scientific standards in which patient safety and data accuracy are put first and considered as the highest goods.
  • Participates in the development and review of clinical reports, for example clinical evaluation reports, periodical clinical updates, clinical justifications for regulatory filings, and slide presentations pertaining to Company’s clinical material.
  • Supports the creation of scientific publications and presentations by implementing publication policy, coordinating with medical writers, providing clinical data and logistic support including investigator communication.
  • Gives continuous input into and participates in the development and maintenance of processes and SOPs. Pro-actively identifies process and/or SOP-related obstacles to effective study conduct.
  • Pursues integration of clinical teams into an effective departmental collaboration and strives to avoid communication deficiencies and related “silo” formation.
  • Shares accountability with others for a positive team spirit that is characterized by mutual support, understanding, encouragement, and an active exchange of new ideas.

Essential qualifications

Technical skills:

  • Clinical background, or extensive clinical research experience in  in the device- or pharmaceutical industry.
  • Ability to assess clinical results summarize into reports, assist in authoring reports and justifications.
  • Operational processes, health care compliance, regulatory requirements, as well as project management skills is required.
  • Extensive knowledge of GCP, GLP, FDA and MEDDEV regulations
  • Understanding of patient care and cardiovascular procedures

Core skills:

  • Strong work ethic and commitment to serve internal and external clients.
  • Energy, focus, motivation, debate-friendly, and good interpersonal skills.
  • Open and honest approach to debates and constant evaluation.  
  • Team player, “can-do” attitude
  • Ability and desire to develop good working relationship internally and externally
  • Excellent written and oral English communication skills
  • Computer skills required

Education:

  • BSc or equivalent in health-related discipline