Governance and Process Assurance Lead; Associate Director level), Medical Affairs; Te

Position: Governance and Process Assurance Lead (Associate Director level), Medical Affairs (12-month Fixed Te
This job is with MSD, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Description
We have an exciting role for a  Governance and Process Assurance Lead (Associate Director level)  in our Medical Governance and Process Assurance team to be based in Moorgate, London.
As the Governance and Process Assurance Lead, you will:
ensure company standards are maintained, identify business risks, and develop mitigation strategies.
author medical quality documents and actively contribute to streamlining company processes to ensure we are an agile digital organisation, acting as the medical voice in innovative projects. This includes SOP simplification initiatives, such as rewriting, updating, and conducting process assurance.
advise on ABPI code and company standards, delivering high-quality service to Medical Affairs and cross-functional teams. Lead responses to challenges, implement monitoring and process assurance, and develop a compliance and governance program to mitigate risks across commercial and medical operations.
The role requires a business-focused, solution-oriented strong leader who can motivate our UK organisation to use an ethical, compliance and governance mindset across all activities.

What you will do:

Advise on the implementation of the ABPI code of practice and company standards, ensuring scientific and ethical standards are met. Act as the lead signatory for high-risk initiatives and the point of contact for relevant activities.
Ensure processes are followed, up to date, and the organization remains audit ready. Implement regular process assurance activities to maintain compliance in all aspects, including medical review, field medical activities, and clinical study management.
Ensure delivery of high-quality service to Medical Affairs and cross-functional team members, including regional, global, and joint venture stakeholders. Collaborate with governance and process assurance colleagues to ensure business-wide alignment.
Lead and coordinate company code training for aspiring and existing signatories, mentor the medical department in relevant aspects of the Code and develop a compliance training program to mitigate risks across commercial operations.
Lead responses to challenges to activities and materials in collaboration with the Head of Governance and Process Assurance, Medical Advisor, Senior Medical Manager, Head of Therapy Area, or DMA. Ensure outcomes of challenges are documented and stored centrally.
Author medical quality documents and actively contribute to streamlining company processes to ensure we are an agile digital organization. Lead SOP simplification initiatives, identify opportunities to enhance efficiencies, and act as the medical voice in innovative projects.
Develop, design, and execute an effective change management and engagement plan for compliance and governance. Proactively identify future business compliance challenges and lead the local development and roll-out of global compliance programs. Implement a robust compliance training and engagement program focusing on critical compliance and governance areas, encouraging adherence, and mitigating risks across all commercial and medical operations.

What you will need:

Medical degree, pharmacy degree or scientific degree accompanied by pharmaceutical industry experience in the field of compliance and governance.
Final signatory/ HCP signatory or AQP signatory.
High level of knowledge of ABPI Code of Practice and UK Regulations governing promotion of medicines.
Experience writing quality documents (policies, standard operating procedures) with high attention to detail, and process assurance auditing.

Skills/competencies:
Attention to detail.
Procedural document writing experience.
Excellent communication skills (verbal and written).
Ability to influence.
Proven decision-making skills in ambiguous situations.
Ability to work cross-functionally.

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