Head Medical Affairs

Job Description Summary

Management of medical affairs & cross-functional guiding, directing, and orchestrating several areas like external medical experts’ engagement, clinical development, patient advocacy, market access, corporate affairs, marketing, regulatory affairs, PV, QA, SCM. Connection regulatory affairs with local country organization.

Job Description

Major Accountabilities

• Develop and lead Medical Affairs strategies including medical communications, engagement with opinion leaders, investigator-led research, HEOR, data dissemination, and external collaborations
• Lead the development of Medical Affairs activities including publication planning, medical advisory boards, educational programs, conferences, and responding to requests for medical information
• Lead MSL field team organization to ensure scientific exchange and engagement related to product and/or TA
• Ensure systems, processes, and enabling technology are in place to support medical team execution
• Provide medical expertise and collaborate in the development of strategies for commercial, market access, business development, and public relations
• Establish professional relationships with the medical community and exchange scientific knowledge with global and regional key opinion leaders in TA’s actively serviced
• Partner with Commercial to ensure timely, accurate, and compliant preparation and review of promotional and educational material
• Work collaboratively with cross-functional partners (e.g. marketing, sales, patient advocacy, clinical,regulatory, legal and market access) to develop and execute strategic plans to execute provider engagement that drive disease awareness
• Develop Key Performance Indicators for medical affairs organization with Executive Team buy-in and report on KPIs regularly
• Foster an environment of compliance and integrity by managing and adhering to all company policies and Legal and Regulatory guidelines
• Maintain and drive the standards of medical and scientific excellence in the Organization through recruitment, training, deployment and development of appropriate associates.
• Maintain full compliance with adverse event reporting to meet statutory regulations.
• Proactive input and leadership as a member of local Sandoz Leadership Team at Sandoz Polska
• Proactively contribute to the development of pharmaceutical medicine and business interests by membership in relevant bodies.
• Ensure connection between RA organization and local business organization; engage to support difficult cases
• Ensure the necessary training and awareness of relevant associates so that Sandoz maintains compliance with current legislation (and Codes of Practice) for promotional activities.
• Follow Sandoz HSE policies and procedures and ensure safety working conditions within the team.
• Under the scope of “CHSE and BC Guideline 12 - Business Continuity Management” and “CHSE and BC Guidance Note 12.1 - Manual of Business Continuity Management”, complete the requirements for ensuring the business continuity of the site and the department.
• Ensure full implementation and execution of all Compliance Policies including but not limited to SP3 Policy and standards across the whole organization.
• Compliance with the Novartis Quality Manual guidelines, in terms of activities and adequate for the area, in accordance with their professional profile and create processes and procedures required for the Quality Management System

Impact on the organization

• Building company’s relation in external medical environment, with patients, and healthcare related officials and institutions.
• Contribution to company’s commercial, Market Access, Portfolio and RA strategy by developing medical strategy and delivering valuable insights.
• Secure appropriate level of scientific medical knowledge across all customers facing functions.
• Secure adherence to legal requirements: medical inquiries, PV, QA and RA obligations requiring with MA Involvement.
• Secure product availability in market and RA compliance by connecting RA with local CO.
• Actively contribute in local SLT work and decision making.

Ideal Background

• Education Medical - graduate from Medical Academy
• Fluent English
• Experience and Skills A minimum of 10 years in various leadership roles.
• Trustworthy with high level of integrity.
• Strong business acumen.
• Sense of urgency; results-oriented, professionally driven, self-starter.
• resourceful, decisive and proactive
• Strong presence and very effective communication skills.
• Excellent relationship building skill.
• Exhibits confidence with external stakeholders.
• Broad understanding of all areas and