Senior Medical Affairs Signatory
- London, United Kingdom
Site Name: Stockley Park
Posted Date: Mar 6 2020
The 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.
- 'Final Signatory': The Senior Medical affairs signatory (SMAS) is responsible for the timely
completion 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 UK
Pharma 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 all
- The SMAS will work closely with the brand-aligned medical and commercial
colleagues 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 resolve
approval 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.
- 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
Our values and expectations are 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, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).
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.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email firstname.lastname@example.org
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