Scientist Physician, Medical Device

Job Title- Specialist, Medical Affairs Physician

Department - Medical Affairs

Purpose - The Specialist Physician is responsible for actively preparing, supporting, and reviewing regulatory, scientific, and promotional materials to ensure medical and scientific accuracy of marketed and new products. This individual also responds to inquiries from internal and external stakeholders (i.e., clinical research, safety, Research and Development (R&D), and other groups). The Specialist Physician may participate in the overall medical/clinical program strategy and implementation.

Primary Responsibilities:

• Provides medical expertise, support, and clarification of science as needed

• Participates in literature search as needed and interpretation of clinical study data in cooperation with Regional and Global Medical Affairs and Clinical R&D

• Identifies and addresses potential medical issues and ensures the implementation of risk-management strategies

• Participates in the development of medical strategies for the medical devices assigned to him/her in the sponsor's portfolio

• Provides medical knowledge and support to commercial, marketing, and sales teams

• Develops and reviews medical content for congresses, symposia, and advisory boards

• Develops and reviews and assists in the revision of strategically targeted information in response to published scientific literature, news media releases, marketing initiatives, product recalls or new or highly publicized medical discoveries or information

• Develops and reviews medical training materials and programs that are used to support initial and continuing training for new employees

• Develops and reviews the standard language for product information reference manuals including Frequently Asked Questions (FAQs) for new product launches, media issues, and publications

• Provides medical support in the review of printed packaging components, labelling, and compendia

• Participates in cross-functional teams as a medical resource for marketed products and new marketed concepts for promotional and non-promotional pieces to ensure medical/scientific accuracy.

• Assists in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.

Secondary Responsibilities:

• Effectively organize and delegate work where applicable to complete the assigned tasks to meet deadlines

• Mentor and bestow domain knowledge to the team.

• Ensure the assigned tasks are delivered 100% on time or before, as per project SLA

• Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work

• Be able to independently perform tasks with minimal guidance & supervision

• Functionally review the team’s work for accuracy and compliance where applicable

• Ensure proper planning of the deliverable and foresee any risks that are likely to arise

• Ensure error free and 100% quality in assigned deliverables

• Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year

• Responsible to ensure training compliance and timesheet compliance

• Conduct functional training for the team members

• Support in the functional capability development of junior members

• Be aware of and comply with the QMS/ ISMS & PIMS Policy.

• Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.

• Contribute towards the achievement of Quality Objectives

Skills and Qualifications

MD Cardiology required in alignment with project / business team requirements

Minimum of 5 to 7 years of relevant experience in identified functional domain/ business workstream.

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