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Job description

Responsible for establishing global medical and scientific strategic direction, short and long-term goals and leadership for the overall planning and delivery of cabotegravir and rilpivirine for treatment and cabotegravir for prevention. group medical affairs activities/initiatives, for internal stakeholders (Medical, Sales, Marketing, VHL LOCs) and external (healthcare professionals, advocacy groups, partner organizations, and HIV patients) customers.

To ensure that internal and external data generated on the mature products is reviewed and followed. Published or presented data that impacts efficacy or safety of the products should be evaluated and appropriate action taken. This can include assessment of label changes, reporting to regulatory authorities, generation of internal Medical Comments, etc. Where appropriate, the Medical Director will lead efforts on education on topics related to these products.

To mitigate risk, ensure that data communication is fair and balanced and complies with emerging regulatory and legal requirements. Assure scientific and information needs of external opinion leaders are met. Ensure compliance with all applicable corporate policies and SOPs.
To develop and maintain programs and processes that enhances the capacity and capability of RML and MSL workforce. Help to generate Global Medical Launch plan to support LOC specific launches. This includes selection, training, development, best practices and communications support.
This role will report to the cabotegravir franchise GML.

Key Responsibilities:
• Provide direct expertise, facilitate medical scientific team expertise for VHL cabotegravir and comparator products to external experts (EE), physicians and other health care providers (HCPs).
• Provide support and systems to maintain standards and ensure compliance with the FDA/MHRA, the GSK Clinical Trial Register and any similar regulatory or VHL processes.
• Maintain a high level of knowledge and expertise in the external regulatory and ethical environment and work to partners within VHL to comment on and influence changes when appropriate
• Provide feedback, input and oversight to ensure contracted Medical Information services provide sufficient resource
• Build and maintain effective relationships and facilitate the provision of scientific expertise with clinical, marketing, commercial, regulatory, compliance and legal to ensure the creation and delivery of scientifically accurate and compliant medical data.
• Ensure the alignment, maintenance and communication of all cross functional Pharma & R&D policies and procedures that support the production and delivery of medical information.
• Partner with Scientific Communications Lead for cabotegravir to develop strategy for scientific communication on cabotegravir and rilpivirine for treatment and cabotegravir for prevention
• Review, provide input and work with VIRET on any ISS proposals related to cabotegravir

Closing date: 25th June 2019

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

When applying for this role, please use the 'cover letter' of the on-line application 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.

Thank you for your interest in this opportunity.

*LI-GSK
*LI-ViiV

Why You?Basic qualifications:
• Specialist clinical practice and/or pharmaceutical industry experience.
• Proven track record interfacing with Commercial operations and other functions
• Proven track record in influencing peers and managing indirect reports in a matrix organization
• Strong Team working and relationship building skills
• Innovation in use of management methods and technology to build new business opportunities and value
• Demonstrated strong influencing skills across and within organizations
• Excellent communication and negotiation capabilities
• Results orientation with an entrepreneurial approach
• Established skills and confidence with external scientific presentation
• An understanding of pharmaceutical drug development

Preferred qualifications:
• Previous medical affairs experience (clinical research, medical information, clinical operations) preferred.

Why GSK?:
Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, at ViiV Healthcare we are determined to help end the HIV epidemic. Our one focused goal unites our 1100 employees located across over 20 countries, with their expertise in research, manufacturing, policy and more, all guided by our mission to be here until HIV isn't.

Our current portfolio of 14 HIV treatments is our first step in fighting back against the disease. This is only the beginning as our research centre in Branford, Connecticut, the world's only HIV-dedicated facility, is utterly focused on finding new innovative medicines to help improve the lives of PLHIV.

Contact information:
You may apply for this position online by selecting the Apply now button.

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.

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