Medical Governance and Operational Excellence Algés

Job Purpose

To provide compliance oversight to ensure that Medical affairs activities are conducted in accordance to local regulations, requirements and guidelines, as well as to applicable procedures for Promotional and SE activities.

Key Responsibilities

• In conjunction with other Medical affairs roles, develops and updates Quality Plan including defining quality controls for Medical Governance risks, coordinating business monitoring activities, assessing issues and managing CAPAS.
• Facilitates risk identification and management. Maintains and updates the risk registry.
• Provides consistent and
  - quality advice on applicable laws and regulations and GSK process related to Medical Governance.
• Actively participates and contributes to the
  - related training of the department.
• Proactive support to all aspects of medical guidance related to the Medical affairs activities. This includes but is not limited to all interactions with external experts and copy approval process of promotional materials.
• To lead the G&D procedure providing guidance and support to Bos and the G&S committee (CMD, finance and compliance) to ensure adequate management and supervision according to GSK internal policies, SOPs and guidelines as well as to applicable laws and regulations.
• Become a process Experts accountable for the compliance local evidence generation implementation and point of contact of the Portuguese medical team (ISS/SCS coordinator).

Basic Requirements

• University degree in Sciences or Health related studies.
• High level of writing English and fluent English speaking.
• Solid grounding in clinical, medical and pharmaceutical science with the ability to rapidly assimilate specific and detailed knowledge in these areas.
• An understanding of clinical development and statistical design and analysis.
• Previous experience in Medical governance assurance.
• Previous experience in medical departments.

Other Job-Related Skills

• Analytical and strategic thinking skills. Able to set and manage priorities.
• Negotiation and conflict resolution skills.
• Assertiveness.
• Proactive and innovative problem solver, influencing the
  - making process.
• Flexible and able to quickly adapt to change. Strong quality mindset.
• Effective networking and collaboration skills to achieve business results.
• A sense of curiosity and a passion for continuous learning and development.

#LI-Hybrid

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2. 5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata. cms. gov/.