GlaxoSmithKline
Director, Medical Information & Content Approval, Vaccines
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Overview
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 informs clinical care and formulary access decisions. This includes 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.
Responsibilities
Leadership:
Lead and oversee the Global Medical Information and Content Approval Team for the Vaccines therapeutic area (TA), who are regarded as subject matter experts for their products within the broader medical organization.
Responsibilities:
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.
Lead and manage team members to ensure performance objectives are met, providing mentorship and coaching 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.
MI and Content Approval:
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.
Ensure team members complete thorough and timely reviews of promotional and non-promotional US and global materials, ensuring content is scientifically accurate, meets the required level of evidence, is fair-balanced, and complies with standards.
Accountable for ensuring MI requirements of the payer strategy for the U.S. are met.
Partner with the GMI Contact Centre (MI CC) Director(s) to ensure MI CC staff are well trained on new products or new scientific data in a timely manner.
Work with business partners and leaders (e.g., Legal, Medical, Clinical, Regulatory, Commercial) to align, validate, and identify solutions to ensure content is of high 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.
Cross-functional Collaboration:
Strategically partner with key global TA and US medical stakeholders to maintain an understanding of the medical strategy of high-priority assets 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 in cross-functional or medical leadership meetings/forums of the TA area of responsibility.
Work with 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.
Qualifications
Basic Qualifications:
PharmD, MD, PhD, or equivalent. 6+ years of experience in the pharmaceutical industry. 4+ years in medical writing and/or promotional review and approval. 4+ years 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 matrix team partners; ability to develop innovative, customer-focused medical solutions. Experience at global and local country levels. Experience in Vaccines. Ability to influence internal and external stakeholders on priorities and needs to fill scientific data gaps. Strong understanding of international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI). 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 conflict resolution skills. Strong clinical literature evaluation and communication skills.
Company and Benefits Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK? 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. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. Our culture emphasizes being ambitious for patients, accountable for impact and doing the right thing so we can 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, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, or military service.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies must contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring candidates. This is a condition precedent to any agreement between the employment business/agency and GSK. GSK shall not be liable for any fees arising from such actions or referrals.
Please note that if you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses in the event you are afforded an interview. This is to ensure compliance with federal and state US transparency requirements. For more information, visit the CMS Open Payments data site.
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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 informs clinical care and formulary access decisions. This includes 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.
Responsibilities
Leadership:
Lead and oversee the Global Medical Information and Content Approval Team for the Vaccines therapeutic area (TA), who are regarded as subject matter experts for their products within the broader medical organization.
Responsibilities:
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.
Lead and manage team members to ensure performance objectives are met, providing mentorship and coaching 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.
MI and Content Approval:
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.
Ensure team members complete thorough and timely reviews of promotional and non-promotional US and global materials, ensuring content is scientifically accurate, meets the required level of evidence, is fair-balanced, and complies with standards.
Accountable for ensuring MI requirements of the payer strategy for the U.S. are met.
Partner with the GMI Contact Centre (MI CC) Director(s) to ensure MI CC staff are well trained on new products or new scientific data in a timely manner.
Work with business partners and leaders (e.g., Legal, Medical, Clinical, Regulatory, Commercial) to align, validate, and identify solutions to ensure content is of high 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.
Cross-functional Collaboration:
Strategically partner with key global TA and US medical stakeholders to maintain an understanding of the medical strategy of high-priority assets 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 in cross-functional or medical leadership meetings/forums of the TA area of responsibility.
Work with 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.
Qualifications
Basic Qualifications:
PharmD, MD, PhD, or equivalent. 6+ years of experience in the pharmaceutical industry. 4+ years in medical writing and/or promotional review and approval. 4+ years 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 matrix team partners; ability to develop innovative, customer-focused medical solutions. Experience at global and local country levels. Experience in Vaccines. Ability to influence internal and external stakeholders on priorities and needs to fill scientific data gaps. Strong understanding of international Codes of Practice (FDA, IFPMA, EFPIA, IPHA, ABPI). 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 conflict resolution skills. Strong clinical literature evaluation and communication skills.
Company and Benefits Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK? 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. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. Our culture emphasizes being ambitious for patients, accountable for impact and doing the right thing so we can 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, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, or military service.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies must contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring candidates. This is a condition precedent to any agreement between the employment business/agency and GSK. GSK shall not be liable for any fees arising from such actions or referrals.
Please note that if you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses in the event you are afforded an interview. This is to ensure compliance with federal and state US transparency requirements. For more information, visit the CMS Open Payments data site.
#J-18808-Ljbffr