Governance and Process Assurance Lead (Associate Director level), Medical Ethics & Integrity - Medical Affairs
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Governance and Process Assurance Lead (Associate Director level), Medical Ethics & Integrity - Medical Affairs
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Job Description
We have an exciting role for a
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.
* 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 training program to mitigate risks across commercial operations.
* actively contribute to streamlining 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 ensuring process assurance.
The role requires a business-focused, solution-oriented strong leader who can motivate our UK organisation to use an ethical, compliance 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.
* Actively contribute to streamlining relevant 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. 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 areas, encouraging adherence, and mitigating risks across all commercial operations.
What You Will Need
* Medical degree or pharmacy degree accompanied by pharmaceutical industry experience
* Final signatory/ HCP 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
* 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 we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.
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 another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Closing date for applications 30th July 2025
Current Employees apply HERE
Current Contingent Workers apply HERE
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.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Required Skills
Adaptability, Clinical Marketing, Data Analysis, Healthcare Education, Interpersonal Relationships, Medical Knowledge, Medical Marketing Strategy, Pharmaceutical Medical Affairs, Project Management, Scientific Communications, Scientific Publications, Scientific Reviews, Strategic Planning, Strategic Thinking, Teamwork
Preferred Skills
Job Posting End Date
07/31/2025
* A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID R356381
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Science, and Health Care Provider
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
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