Director, Medical Information & Content Approval, Vaccines

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The Director, Medical Information & Content Approval, Vaccines plays a critical role in managing a team that ensures the US and global promotional and non-promotional content meets the highest standards of quality, scientific accuracy, balance, and compliance that meets the scientific needs of customers to help inform clinical care and formulary access decisions. This includes ensuring the adherence to internal GSK standards and applicable external regulations, including an understanding of the ABPI code of practice. This role supports the Sr. MI &CA Director to develop and execute the Medical Information and Content Approval strategy, including innovative digital MI solutions. The Director serves as an influential partner to Medical Affairs, Commercial and other key business stakeholders. Key Responsibilities: Lead and oversee the Global Medical Information and Content Approval​ Team for the Vaccines therapeutic area (TA), who are sought out as subject matter experts for their products within the broader medical organization.
Contribute to the development and execution of the Global Medical Information and Content Approval strategic priorities, including digital solutions, to ensure internal/external stakeholder information needs are optimally met.
Leading and managing team members to ensure performance objectives are met, providing mentorship and coaching team to support development and resolve challenges.
Mentor and develop team members, ensuring they have adequate training and tools, and facilitate their professional development through differentiated development plans.
Act as a delegate of the Senior Director, Medical Information and Content Approval at Leadership team meetings and other relevant meetings requiring TA specific leadership attendance, as required.
Accountable for MI launch readiness plans including planning and maintaining a robust, high quality and up to date MI database incorporating medical insights to help inform clinical decision making by HCPs
Maintain a robust understanding of, and stay up to date with changes to, the ABPI Code of Practice and other regulatory guidelines to assist team members and escalate, when appropriate.
Ensures team members complete thorough and timely review of promotional and non-promotional US and global materials, ensuring content is scientifically accurate, meets the scientific rigor (i.e., levels of evidence); is fair-balanced and meets the compliance requirements/standards.
Accountable for ensuring MI requirements of the payer strategy for the U.S are met.
Work alongside various business partners and leaders (e.g., Legal, Medical, Clinical, Regulatory, Commercial) to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience.
Support GMI&CA team activities (e.g. MI content creation, medical review and approval), when required and in onboarding new team members.
Strategically partner with key global TA and US medical stakeholders to maintain a good understanding of the medical strategy of high-priority assets of the TA and ensure MI meets the needs of HCPs worldwide.
Ensure effective scientific exchange with external customers, driving excellence in MI activities at important US and Global Congresses, leveraging innovative digital solutions.
Represent Medical Information and Content Approval on cross functional or medical leadership meetings/forums of the TA area of responsibility.
Work alongside various business partners and leaders (e.g., Legal, Medical, Clinical, Regulatory, Commercial) to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience.
Why You? Basic Qualifications: PharmD, MD, PhD, or equivalent.
6+ years of experience in the pharmaceutical industry.
4+ years of experience in medical writing and/or promotional review and approval.
4+ years of experience in customer-focused, problem-solving, and conflict resolution roles.
Experience in people leadership, management and development
Experience working in a highly dynamic, changing, and matrixed environment.
Preferred Qualifications: Experience communicating and translating evidence and customer insights to/with matrix team partners; proven ability to develop innovative, customer-focused medical solutions and resources
Experience of working at both global and local country level
Experience in Vaccines
Experience influencing internal and external stakeholders on priorities and needs to fill scientific data gaps or needs of external customers
Strong understanding of international Codes of Practice FDA, IFPMA, EFIPIA, IPHA, ABPI, etc.
Experience in reviewing and approving promotional and non-promotional content
Ability to develop and maintain strong trusted relationships with internal stakeholders.
Demonstrated customer-focus, problem-solving abilities, and strong conflict resolution skills.
Strong clinical literature evaluation skills
Strong communication skills
Please visit to learn more about the comprehensive benefits program GSK offers US employees. 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. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
Location:
Montgomery County
Job Type:
FullTime