As an Associate Director, Content Approval for Vaccines, you will play a pivotal role in ensuring the global promotional and non-promotional content meets the highest standards of quality, scientific accuracy, balance, and compliance. This includes adherence to internal GSK standards and applicable external regulations, including a robust understanding of the ABPI code of practice. This role will involve the fostering of robust relationships and collaborations within a highly matrixed environment which includes but is not limited to Commercial, Legal, Medical Affairs, Regulatory Affairs, Clinical Development, and third-party suppliers at a Global level.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Key Responsibilities:

This role will provide you the opportunity to utilize your expertise in the scientific area, understanding of the internal business strategies, applicable GSK processes/policies, and the external regulations including the ABPI code of practice to ensure global content is compliant, accurate, up-to-date, and fit for purpose for external engagement.  These responsibilities include the following:

• Primary medical reviewer and/or approver who is accountable for the thorough, timely review and approval of Global promotional and non-promotional materials.

• Ensure content is scientifically accurate, meets the scientific rigor (i.e., levels of evidence); is fair-balanced and meets the GSK requirements/standards/processes as well as complies with applicable external regulations (incl. ABPI Code where relevant)

• Maintain a deep understanding of ABPI Code of practice (as an AQP/Appropriately Qualified Person), regulatory requirements, industry standards, best practices, and the GSK interpretation/position to ensure consistent application while reviewing and/or approving global medical or commercial content in scope of ABPI.

• Strong understanding of the business strategies/unmet needs to ensure the content is aligned with current medical practices/guidelines, and the content is fit for purpose to the targeted audience. 

• Work alongside MI counterparts and various business partners to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience and support other GMI&CA team activities

• Serve as a key point of contact for regulatory and legal teams during audits and inspections, providing documentation and insights as needed

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Master’s/Graduate Degree in Life Sciences or Healthcare

• Significant pharmaceutical industry experience 

• Significant Medical Affairs experience as a reviewer of content used in promotional and non-promotional settings

• Experience with commercial and medical activities from a global perspective in the pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards)

• Strong understanding of content approval requirements incl. external regulations (e.g. ABPI Code) 

• Strong understanding of international Codes of Practice FDA, IFPMA, EFIPIA, IPHA, ABPI etc.

• Experience with evaluation of clinical literature

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Experience of working at both global and local country level 

• Experience working with global teams in a matrix environment

• Experience in Vaccines

• Ability to accurately evaluate and summarize complex scientific literature, real-world evidence, and other observational research studies for scientific evaluation needs by various customer types

Closing Date for Applications – 11th of May(COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more:  

Our approach to R&D.   

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a  Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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/