Sr Global Medical Director - 29372BR - EN
The Senior Global Medical Director will be responsible for Corporate medical safety processes and activities. His/Her focus will be on supporting pre and post market activities such as clinical research, medical assessments, adverse event reporting (MDR), recalls, and health authority interactions.
- Provide medical safety governance as well as establishing and implementing a strategy for the medical safety community (maturity models)
- Lead the Company in developing and updating corporate medical safety associated procedures to ensure alignment and compliance to regulatory expectations as well as consistency of medical evaluations.
- Develop and disseminate associated medical safety training to Divisions, Sites and third parties providing services in this area, as appropriate.
- Act as a liaison amongst the medical safety community across the corporation.
- Responsible for effectively communicating and escalating issues regarding Site and Division medical safety performance to the appropriate Division or Corporate level.
- Partner with Corporate Process Owners to ensure medical safety responsibilities are effectively defined in related processes.
- Assist Stryker's Corporate management in evaluating and making decisions on product risks and potential safety issues, including:
- Evaluation of complex complaints and adverse event trends and reporting (e.g. MDR/MDV), unanticipated product performance trends and other internal and external sources of quality and risk data.
- Interaction with regulatory agencies and external health care practitioners on product safety issues.
- Providing medical support for risk management activities throughout product life cycle, as requested.
- Responding to Off-label inquiries, as requested.
- Provide expert medical support to new product development, legal, clinical research and regulatory departments as requested.
- Assist in selecting qualified medical consultants as requested.
- Represent Stryker on medical safety issues with worldwide regulatory bodies as requested.
- Provide medical guidance for regulatory submissions as requested.
- Serve as medical safety representative for Stryker at scientific meetings, standardization bodies and regulatory meetings.
- Assist with due diligence evaluation of medical data for potential business acquisitions.
- Support medical issues associated with Mergers & Acquisitions.
- Provide medical guidance to all aspects of Stryker's business.
The successful candidate for this position will be an experienced and respected medical executive, with a background in a surgical discipline. He/she should possess the following experiences and qualifications:
A medical doctor degree is required.
- Former regulator or hospital/healthcare administrator preferred.
- Proven track record of increasing levels of responsibility in medical affairs or clinical development roles with medical products companies.
- Extensive interaction with and understanding of health authority expectations with regard to health risk assessment.
- Experience with and ability to provide overall medical guidance for a company or business division.
- Program Management of pre and/or post-marketing trials, inclusive of investigator-initiated trials (both preferred).
- Excellent interpersonal and presentation skills.
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