Senior Specialist, Global Medical Information

Senior Specialist, Global Medical Information

The Senior Specialist, Global Medical Information is an entry-level headquarters (HQ)-based role within V&I Global Medical and Scientific Affairs (GMSA), responsible for the US and global core functions of the GMI organization: Medical Information, which includes handling of all US healthcare professional (HCP) inquiries and escalated complex global HCP inquiries as well as generating insights and analysis; Medical Review of promotional and non-promotional scientific materials; Training of internal stakeholders; and Compendia and Pathways Submissions.

The Senior Specialist has an advanced educational background and reports into the Director, Team Lead. The responsibilities and activities of the Senior Specialist are focused on the US and global core functions of GMI with guidance from senior GMI colleagues (e.g., Associate Director, Director, and/or Director, Team Lead).

Responsibilities and Primary Activities

Accountabilities

Medical Information: Customizes responses to standard and complex US Medical Information requests (MIRs) from HCPs/scientific leaders/payers in writing and/or verbally utilizing scientific response documents (SRDs), conducting literature searches, and/or reaching out to subject matter experts (SMEs) in another area of the Company. Staffs Medical Information booths at HQ-sponsored US and international congresses to verbally answer unsolicited inquiries from HCPs. Responsible for generating insights from Medical Information capabilities to inform strategic planning and identify gaps in data for appropriate stakeholders.

Medical Review of US and global promotional and non-promotional scientific materials: Reviews and approves US and global promotional materials from internal Human Health (HH) stakeholders and external partners and non-promotional scientific materials from the Global Scientific & Value Content (GSVC) team to ensure content, messaging, and comparisons are relevant, medically and scientifically accurate, balanced, provide appropriate context, and are consistent with cited appropriate scientific literature, internal scientific information and all applicable Company policies, local regulations, and department SOPs. Conducts medical/scientific review of certain study results plain language summaries (RPLS) that will be posted publicly as part of the Company's commitment to study results transparency in the EU and US (in partnership with Regulatory Affairs) and submissions to CMS for price negotiations for certain products under the Inflation Reduction Act to ensure that the medical information put forth by the Company is relevant, complete, balanced, and valuable to decision-makers (in partnership with V&I Outcomes Research).

Training: Collaborates with internal stakeholders to determine the educational objective of training materials and identifies training gaps. Contributes to the development/creation and delivery of medical/scientific training materials to Our Company's National Service Center (NSC), field sales representatives, and US Medical Affairs field-based employees. Participates in training of standard operating procedures and processes for internal stakeholders. Compendia and Pathways Submissions: Engages and collaborates with SMEs and relevant stakeholders in the planning, development, review, and approval of product data submissions to Compendia and Pathways organizations.

Cross-Functional Collaboration

• Develops relationships and partners with Director, Team Lead, senior GMI colleagues, and other key internal stakeholders (across V&I Global Medical & Value Capabilities [GMVC], V&I GMSA, V&I Outcomes Research, NSC, Clinical, Labeling, Safety, our Manufacturing division, Legal, Compliance, OPAR, Marketing, Promotions, Regulatory Affairs, etc.) as well as external stakeholders to share capabilities/ideas and meet priorities and business needs.
• Serves as a resource and SME within the therapeutic area for the US and global core functions of Medical Information, Medical Review, Training, and Compendia and Pathways Submissions.

Enterprise Leadership Skills:

• Inclusion: Values different perspectives and conveys respect for individuals of cultures, interpersonal styles, motivations, and backgrounds
• Strategic Planning: Appropriately prioritizes activities and assignments to meet timelines and works efficiently with internal and external stakeholders
• Talent Growth: Embraces continuous learning by seeking feedback to identify and participate in appropriate learning activities
• Networking and Partnerships: Develops and maintains effective working relationships with internal and external stakeholders who have the knowledge, experience, and resources to achieve results
• Ownership and Accountability: Assumes responsibility and accountability for successfully completing tasks or assignments and sets high standards for personal performance

Required Qualifications, Skills, & Experience Minimum:

• Relevant advanced degree (PhD, PharmD, MSN, MS or equivalent)
• Prior medical information or medical/scientific review or relevant biotech/pharmaceutical experience
• Some experience or knowledge in specified therapeutic area
• Basic knowledge of clinical trial methodology, statistical concepts, and evaluation and interpretation of complex scientific literature
• Solid awareness of the function and value of Medical Information
• Excellent interpersonal, communication (written and oral), and presentation skills
• Strong organizational, prioritization, and multi-tasking skills

Preferred

• Two years of medical information or medical/scientific review or relevant biotech/pharmaceutical experience
• Advanced experience or knowledge in specified therapeutic area
• Negotiation skills for interaction with cross-functional teams
• Strong critical thinking and analytical skills and ability to consolidate and understand complex data sets
• Ability to work in a complex organizational environment and effectively operate in a team-oriented structure as well as by oneself

Required Skills:

Adaptability, Clinical Trials, Cross-Functional Collaboration, Data Analysis, Healthcare Education, Insight Generation, Interdisciplinary Collaboration, Literature Searches, Medical Affairs, Medical Communications, Medical Knowledge, Medical Review, Medical Writing, Negotiation, Pharmaceutical Medical Affairs, Prioritization, Professional Integrity, Project Management, Promotional Review, Scientific Literature, Stakeholder Management, Statistical Theory, Strategic Planning, Strategic Thinking, Team Orientation

Preferred Skills: