Director, Medical Governance, Emec

vor 3 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Medical Governance is a framework of company policies, principles, and responsibilities under the authority of the Chief Medical Officer (CMO) that enable high ethical and quality standards across the organization. The Director, Medical Governance, EMEC, provides expertise and support on Medical Governance to the regional and country teams; collaborates with cross-functional stakeholders such as compliance, legal, the respective global organizations/departments and vendors; puts ethics and business integrity into action whilst facilitating the overall company and commercial strategy.

Specifically, the responsibilities of the role include (not limited to):
Providing strategic and operational guidance for medical activities in the region, coordinating with the Regional and Global Medical Affairs teams.

Medical governance with medico-marketing and other activities associated with Health Care Practitioners and Health Care Organizations.

Acting as the Medical Governance representative for the region.

Operationalizing strategy and key processes/systems related to Medical Affairs activities in line with standards with and across team.

Developing a collaborative relationship with the local Country Medical Director and medical team members to support early adoption of global initiatives.

Working closely with the countries to assist in rolling out global processes and associated programs. Reporting back to global when simplification is needed in global processes. Ensuring that all main medical activities are well implemented and followed.

Liaising between Global Medical, Regional Medical, and other functional partners and its region in the implementation of the medical governance guiding principles to ensure compliance with the company standards and processes.

Providing guidance on Medical Governance through training of medical staff on good practices (quality and compliance mindset, best medical practices, regulatory obligations, etc).

Onboarding and training on medical processes for all local & regional medical employee.

Ensuring that appropriate access to unapproved medicines for treatment, as well as expanded and early access and compassionate use be conducted according to company policy.

Coordinating regional review as appropriate of medical, quality, safety materials and ensure operational execution.

Facilitate discussions between internal/external stakeholders with optimal decision outcomes so that both promotional and non-promotional interactions meet applicable standards and requirements. These activities include (not limited to): field-based medical interactions, medical education, advisory boards, publications/scientific communications, medical information, patient engagement & advocacy, patient support programs, sponsorships, grants and donations, expert paid consultancies.

Enhancing quality and regulatory compliance for medical activities through oversight of relevant quality and risk management (including the framework for issue management escalation).

This is an exciting time to join Moderna as we expand our product reach globally to hundreds of millions of people and experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. This role will be a key contributor to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

**Here's What You’ll Do**:
Define key principles for a medical/commercial framework to enable agile and compliant interactions both at global and local level.

Design, review and update relevant company polices and guidelines while ensuring alignment with Legal, compliance, clinical, medical and commercial relevant functions.

Define and oversee appropriate early access and named patient programs across the pipeline.

Define new guidelines, where appropriate, and oversee innovative digital approaches to data collection and dissemination.

Ensure alignment to regional/local requirements while retaining the same overall central principles.

Oversee company approval processes for promotional and non
- promotional content.

Prepare organization for related company audits.

**Here’s What You’ll Bring to the Table**:
Extensive experience in Global Biopharmaceutical industry across different therapeutic areas.

Life sciences degree, preferred level M.Sc. equivalent or higher.

Significant leadership experience in medical governance working with Commercial and Medical interface for promotional and non-promotional activities, including digital technology.

Experience in Bioethics.

Ability to consider different perspectives/needs and make a principle-based/balanced/optimal decisions.

Proven expertise leading people both directly and in a matrix environment.

Highly self-motivated, with a track record of excelling in a fast-paced work environment.

Proven ability to lead remotely and effectively manage int

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