Head Legal Medical Affairs, International

Band

Job Description Summary

Job Description

Key responsibilities:

• Strategic Legal Counsel Provide strategic legal leadership for Medical Affairs across international markets enabling compliant scientific exchange evidence generation and timely highquality medical engagement. Set clear guardrails for nonpromotional activities (including publications grants/IITs RWE digital channels and patient interactions) in line with laws industry codes and internal governance (e.g. scientific review committees SOPs). Offer pragmatic counsel and proactively identify opportunities risks and solutions grounded in a deep understanding of Medical Affairs across Novartis.

• Medical Governance Standards & Controls Advise on medical governance and the design and implementation of international/global standards and processes for medical programs. Define the boundaries between nonpromotional medical/scientific exchange and promotional conduct and operationalize guidance for field medical congresses and digital channels.

• Scientific Exchange MLR and Review Governance Coown and enhance SOPs for Medical/Legal/Regulatory (MLR) and Scientific Communications ensuring roles accountabilities and documentation standards are clear and auditable. Oversee legal review of medical materials (e.g. scientific decks FAQs Q&A disease awareness congress content) to ensure substantiation alignment with approved information and compliance with local codes.

• Medical Engagements and Advisory Activities Support compliant frameworks and systems for HCP engagements including advisory boards expert panels KOL engagements FMV contracting standards conflictofinterest management and transferofvalue transparency. Advise on speaker training medical education and thirdparty scientific events to ensure nonpromotional conduct. Set guardrails for medical websites portals webinars social media and virtual advisory activities including audience qualification and access controls.

• Medical Excellence and Innovation Drive innovation and contribute to strategies supporting Medical and International objectives with emphasis on launches and new engagement models for HCPs patients and healthcare systems. Advise on and oversee governance for medical excellence programs. Monitor and manage legal risks related to AIassisted content medical chatbots and digital medical education tools while driving simplification.

• Risk Management / Compliance Partner with Ethics Risk and Compliance to proactively identify and manage compliance risks. Help ensure adherence to applicable regulations and mandates. Contribute to responses to audits regulatory inquiries and investigations related to medical activities and manage disputes and corrective actions with outside counsel as needed.

• Policy Monitoring Capability Building & Training Track industry trends and evolving laws and codes (e.g. IFPMA/EFPIA and local codes) including transparency antiinducement anticorruption and health regulations. Translate changes into practical guidance playbooks SOP updates and targeted training for International on scientific exchange and engagements. Build a community of practice to share case law regulatory trends and lessons from audits/HTA interactions involving Medical.

• Functional Reporting Alignment & Collaboration Report to and regularly update the Head Legal CLS IMA and V&A and other senior GMA/IMA/business leaders on key IMA matters. Foster collaboration and information sharing with CLS Legal Regional and Country Legal R&D and especially GMA Legal ensuring alignment on key legal matters within IMA scope.

• Governance Actively participate and contribute in relevant medical governance bodies in IMA (and GMA as applicable).

• Functional Leadership Contribute to International Regional and Country Legal functions by leading or joining initiatives that build departmental knowledge and capabilities share best practices and provide specialized expertise to colleagues.

Essential Requirements:

• Juris Doctor (JD) or equivalent law degree along with a prior Bachelors degree.

• Extensive experience providing legal counsel within the pharmaceutical or biotechnology industry with a strong track record in product launches.

• Broad knowledge of legal issues relevant to the pharma/biotech sector including regulatory commercial medical transactional integration privacy and AI/digital/social media matters.

• Familiarity with medical affairs activities and operations RWE pharmacovigilance and regulatory frameworks across multiple markets.

• Demonstrated people leadership within matrix organizations managing developing and coaching teams - both directly and indirectly.

• Exceptional negotiation and conflict management abilities.

• Fluent in both written and spoken English.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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