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Senior Medical Affairs Signatory

GSK
Job LocationStockley Park
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: Stockley ParkPosted Date: Mar 6 2020The Copy Approval Team (CAT) provides an aligned approach to copy approval through a focused and expert platform, covering GSK UK Pharma’s entire portfolio of medicines and activities. This approach has enabled the quality and efficiency of the copy approval process across the UK organisation to be improved.The CAT provides a hub of copy approval knowledge, expertise and activity across UK Pharma including the application of the ABPI & GSK Codes of Practice to GSK’s promotional and non-promotional materials and practices.There are some new and exciting planned changes coming to the ABPI Code in 2021 and 2019/2020 will be key in planning the implementation of these.We are preparing for Oncology next year and the successful candidate whilst starting off in our exciting respiratory portfolio will also have the opportunity to work on developing expertise and experience in other therapy areas.Key Responsibilities

  • ‘Final Signatory’: The Senior Medical affairs signatory (SMAS) is responsible for the timelycompletion of compliant review, approval and certification of the majority (>65%) of promotional and non-promotional materials, activities and meetings in line with ABPI and GSK Codes of Practice across UK Pharmaceuticals and other business units as required by the business.
  • Approvals system expert: An expert in GSK’s copy approval system, ContentLab, the SMAS will work with the ContentLab Superusers to establish a uniform approval excellence approach across the Commercial and Medical teams.
  • The SMAS is also expected to lead continuous improvement efforts with the brand-aligned Commercial and Medical teams to enhance the copy approval process and systems in an ongoing fashion.
  • Code Complaints & Intercompany Dialogue: The SMAS is accountable for ensuring that UKPharma has an efficient and compliant process for managing ABPI Code complaints. In addition to being the process owner, the SMAS will be required to co-ordinate and develop responses to complaints received from the Prescription Medicines Code of Practice Authority (PMCPA), including any potential appeals.
  • The SMAS may also be involved in managing inter-company dialogue and take the lead on identifying and challenging potential ABPI Code non-compliances as required by the business.
  • Team player: Extensive cross-matrix integration with multiple teams across GSK’s therapy areas, demonstrated through developing and maintaining good working relationships with allstakeholders.
  • The SMAS will work closely with the brand-aligned medical and commercialcolleagues supporting their full scope of activities to include the development of campaign,meeting and educational materials.
  • Decision maker: Work with teams supporting smart risk taking through providing Code,governance and compliance expertise.
  • The SMAS will successfully manage and resolveapproval issues, managing conflict where required with project owners and counter signatories.
    • The SMAS is responsible for reliable and regular participation at compliance accountability meetings and ensuring all other necessary specialist inputs are incorporated as required.Why you Basic Qualifications:
  • UK Registered Pharmacist or GMC Registered Doctor
  • Experience within UK Medical Affairs
  • Copy approval knowledge / experience in the pharmaceutical industry with solid experience of working as a final signatory. Strong familiarity with and confidence in the ABPI Code of Practice and its application
  • Strong familiarity with and confidence in implementing compliance frameworks
  • Experience of using ContentLab/Veeva Promomats or similar/ other copy approval systems
  • Therapy knowledge in one or more of the following therapeutic areas: Respiratory, Vaccines.
  • Ability to identify and manage risk
  • Ability to demonstrate good balance between controls and competitiveness without any compromise in compliance
  • Confidence in decision making, problem solving capability and ability to rationalise and document carefully evaluated decisions
  • Structured mindset, proactive, self motivated and self reliant
  • Ability to prioritise and organise workload, and think clearly under pressure and time constraints and work with pace and focus in a fast-paced environment
  • Ability to facilitate internal relationships across disciplines and network within both the UK Company above country functions and the external stakeholders.
  • Clear communicator with sufficient business acumen and experience to enable communication and engagement with key stakeholders supported by influencing, challenging and negotiating skills.
    • Preferred Qualifications: If you have the following characteristics, it would be a plus:
  • UK Registered Pharmacist (or Medical Practitioner) with an active and current ABPI Signatory status
    • Why GSK Our values and expectationsare at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.Building strong relationships and collaboration, m

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