Medical Device Quality Manager jobs in Remote

Job Description

General Summary:

The Senior Manager Medical Information drafts and maintains medical information content for use by the Medical Information Call Center (MIC) staff to respond to medical inquiries from healthcare professionals
and patients. The Senior Manager Medical Information reviews MIC case records for accuracy of response and appropriate case processing in compliance with applicable policies, SOPs and country specific
regulations and/or guidance.

Key Duties and Responsibilities:

• Develops and maintains in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information to facilitate the creation of medical content.
• Drafts standard medical response letters and frequently asked questions (FAQs) for assigned product(s) and/or investigationals that are timely, non-misleading, accurate, and scientifically balanced for assigned Vertex marketed products and/or investigationals and relevant diseaserelated topics for use by MICs to respond to commonly received unsolicited medical inquiries.
• Provides guidance to Medical Information Managers on the appropriate methods for drafting standard medical responses (letters and FAQs).
• Works cross-functionally with other subject matter experts (SMEs) in Medical Affairs, Regulatory Affairs, Formulations and Pharmacovigilance to send response drafts (letters and FAQs) for review and approval to ensure drafts are accurate, compliant and appropriately address the topic of the inquiry. Creates standard language templates based upon SME review and approval.
• Utilizes therapeutic knowledge and clinical expertise to independently draft timely, nonmisleading, accurate, and scientifically balanced custom responses to new and/or unusual unsolicited medical information inquiries concerning assigned product(s). Provides guidance to
• Medical Information Managers on the appropriate methods for drafting custom medical responses.
• Reviews medical information call center case records (medical inquiries, potential adverse events, and potential product complaints) to ensure quality and accuracy of response and appropriate case processing.
• Drafts metric and insight reports for use by medical information upper management and strategic business partners.
• Fact checks medical and marketing content, related to assigned product(s) and/or investigationals in the electronic review and approval system, for accuracy and appropriateness and relays all discrepancies to the appropriate subject matter expert or final approver.
• Monitors the medical literature for additional sources of product information and content for use in the creation of medical information materials

Knowledge and Skills:

• Excellent oral and written communication and literature searching skills to explain difficult information
• Experience drafting medical information content with a high degree of accuracy and accountability
• Sound knowledge of the stages of drug development and the available corporate and public resources used to construct a medical information response
• Ability to work collaboratively in a dynamic, team-based matrix environment and to function independently as appropriate
• Strong working knowledge of the rules and regulations governing the provision of Medical Information in Pharma
• Analytical skills and an ability to synthesize data sets and study summaries into meaningful oral or written communication materials

Education and Experience:

• Bachelor’s degree in a health-related science
• Typically requires 6 years experience, with 2 years experience working in either Medical Information or Medical Affairs in a biotech/pharma or equivalent combination of education and experience.

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote : work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid : work remotely up to two days per week; or select
3. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com