Director, Medical Information & Content Approval, Vaccines

GSK•Durham, PA

26d

About The Position

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.

Requirements

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.

Nice To Haves

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

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.
Partner with GMI Contact Centre (MI CC) Director/s to ensure the MI CC staff are well trained on new products or new scientific data in a timely manner.
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.