Legal Specialist

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the Medical Information Specialist role, will make an impact:

Role Purpose
Medical Information Specialist is responsible for providing technical and scientific support for responding to unsolicited inquiries. A key activity is researching, creating and updating Global Scientific Response Documents to answer unsolicited medical inquiries. The role may also involve management of escalated inquiries, peer review of other colleagues' work, providing literature services and participating in global medical information projects and initiatives. The role has Global scope of responsibilities, requiring membership of Global teams and regular interaction with Global colleagues.

Key Responsibilities
Creates, maintains and reviews Global Scientific Response Documents (GSRDs) and other related content in different formats by ensuring that responses are medically and scientifically accurate, timely, fair balanced and meet customers' needs. Effectively manages relationships with global colleagues to facilitate timely authoring and review.
• Exhibits comprehensive knowledge of MI work and processes as well as good understanding of other local MI stakeholders
• Researches and analyses and summaries scientific information taking local labeling and regulatory into consideration to answer escalated MI inquiries
• Performs high quality searches of medical literature in response to customer inquiries or as it relates to creating/updating MI document, maintains literature search pool in global platform
• Delivers accurate and balanced query response to internal and external customers via creating or updating local standard response documents (LSRDs) based on actual and anticipated customer demand for aligned products, within agreed timelines.
• Reviews LSRDs based on actual and anticipated customer demand for aligned products and education among team.
• Understands and complies with all applicable policies, guidelines, and regulations related to the work being fulfilled (may be specific to country of origin).
• As a member of Global Product Teams, collaborates with Global colleagues to develop clear understanding of customer needs, ensure an open exchange of product information, business intelligence and best practices
• Supports provision of MI training including Medical Writing to immediate team colleagues as well as those in the nearby regions.
• Serves as a subject matter expert (and as needed, Global Product Champion) for MI on responsible product(s) and associated therapeutic area(s)
• Exhibits comprehensive knowledge of the MI work and processes as well as good understanding of other internal stakeholders, and can act as a mentor/SME on these topics to junior colleagues.
• Proactively seeks new innovative solutions to improve MI processes and responses and to resolve problems
• Leads product sub-teams, working groups and MI projects/initiative teams with global or regional impact as needed (e.g. Fact Check, GTAT –on-Demand portal)
• Contributes the global project to identify local requirement for continuous improvement based on team needs.
• Works as TA Lead to develop aligned MI TA group by providing customer insight/business trend from daily interaction with customers on a regular basis via team quarterly report and product/ therapeutic area team meeting

Supervisory/Management Responsibilities
No direct supervision, provides direction to others

Position Accountability Scope
Global

Qualification and Experience
Educated to Scientific or Medical degree level or equivalent
Ability to conduct an in-depth analysis of published and unpublished data and engage cross-functional colleagues to identify appropriate resources to utilize in addressing complex medical information inquiries
Have hands on medical Information and Medical Writing experience (3+ years)
Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical information (3+ years)
Understanding of and adherence to regulatory policies governing scientific interactions with HCPs and patients (2+ years)
Experience with GxP requirements and reporting of adverse events with a general understanding of world-wide requirements for MI and PV (2+ years)
Experience with data management (CRM/CMS platforms) and informatics/analytics (3+ years)
Bachelor's Degree in Pharmacy/Medical/Life Sciences or related field required. Higher degree (e.g. Masters, PhD degree) preferred
English proficiency required for this role: Advanced

---