Governance and Process Assurance Lead (Associate Director level), Medical Affairs (12-month Fixed Term Contract)

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 arean 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.

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively for the common good. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully:

Our Company is not accepting unsolicited assistance from search firms for this employment opportunity. Please no phone calls or emails. All resumes submitted by search firms to any employee at our Company via email the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our Company. No fee will be paid in the event the candidate is hired by our Company as a result of the referral or through other means.

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Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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