Sr Global Medical Director in Allendale, NJ at Stryker Corporation

Date Posted: 8/29/2018

Job Snapshot

Job Description

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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.

Primary Responsibilities:
  • 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.

 

*Minimum Qualifications

Minimum Qualifications:
 
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.

Work From Home: Yes

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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