Medical Affairs Signatory (Senior)

Full time Pharmacistweb in Pharmaceutical Email Job
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Job Detail

  • Career Level Manager

Job Description

Your Responsibilities:
This is an exciting time to join our team, providing a dedicated expert in house solution to all matters relating to promotional and non-promotional activities within the UK.

Join a leading team which provides expertise on training, mentoring, and system support along with signatory support.

Key Responsibilities
• You will be responsible for the timely completion of compliant review, approval and certification of the majority of promotional and non-promotional materials, activities and meetings in line with ABPI Codes of Practice across UK Pharmaceuticals and other business units as required by the business.
• An expert in copy approval system, you will work to establish a uniform approval excellence approach across the Commercial and Medical teams. You are expected to be dedicated to continuous improvement. Your efforts should also ensure alignment with Commercial and Medical teams to enhance the copy approval process and systems.

  • Code Complaints & Intercompany Dialogue: You will be accountable for ensuring that the UK
    business has an efficient and compliant process for managing ABPI Code complaints. In addition
    to being the process owner, you 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. You 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 various therapy areas, demonstrated through developing and maintaining good working relationships with all
    stakeholders. You 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. You will successfully manage and resolve
    approval issues, managing conflict where required with project owners and counter signatories.
    You will be responsible for reliable and regular participation at compliance accountability
    meetings and ensuring all other necessary specialist inputs are incorporated as required.
    • Accountability for Training & Mentoring: You will be accountable for creating and deliver training
    on code compliance issues for the organisation as the expert of the code of practices. Examples
    of training interventions (not exhaustive) include developing other signatories, providing general
    updates and training to the organisation, providing insight and updates based on changes in
    codes of practice, designing and delivering interventions following audits or self-inspections
    • Self-development: Continuously maintain self-signatory status via attendance Code & Governance Forums and keeping an up-to-date working knowledge of all relevant laws, regulations, codes, policies and SOPs through internal and external methods.
    • Governance development: Participate in writing, training and maintaining SOPs related to copy approval and governance to constantly enhance and improve the in-house approval process.
    • Audit: You will be responsible for ensuring UK business are audit ready from a code of practice perspective alongside the UK management monitoring process to identify trends that need proactively addressing.Please use your covering letter to highlight how you fit the applicant profile and meet the skills and competencies for the role. Your covering letter, along with your CV, will be used to assess your application.

Basic qualifications:
• UK Registered Pharmacist (Pharmacists must hold an up to date registration with the General Pharmaceutical Council (GPC) and be actively undertaking continual professional development (CPD) assessed by the GPC)
• 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:
UK Registered Pharmacist (or Medical Practitioner) with an active and current ABPI Signatory status

 

Required skills