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- Tasks: Lead governance and process assurance in medical affairs, ensuring compliance and quality standards.
- Company: Dynamic pharmaceutical company focused on innovation and diversity.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact in global medical advancements while working with diverse teams.
- Qualifications: Medical or scientific degree with experience in compliance and governance.
- Other info: Join a collaborative environment that values diverse ideas and encourages innovation.
The predicted salary is between 43200 - 72000 £ per year.
We have an exciting role for a Governance and Process Assurance Lead in our Medical Governance and Process Assurance team to be based in Moorgate, London.
Key Responsibilities:
- 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.
- 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.
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 we are 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 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.
Governance and Process Assurance Lead (Associate Director level), Medical Affairs (12-month Fixed Te employer: Merck & Co., Inc.
Contact Detail:
Merck & Co., Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Governance and Process Assurance Lead (Associate Director level), Medical Affairs (12-month Fixed Te
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working in governance and process assurance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on the ABPI Code of Practice and company standards. Show us you know your stuff and can discuss how you’d ensure compliance and quality in medical affairs.
✨Tip Number 3
Don’t just apply; engage! When you submit your application through our website, follow up with a quick email expressing your enthusiasm for the role. It shows initiative and keeps you on our radar.
✨Tip Number 4
Be ready to showcase your document writing skills. Bring examples of your previous work, like SOPs or quality documents, to demonstrate your attention to detail and ability to maintain high standards.
We think you need these skills to ace Governance and Process Assurance Lead (Associate Director level), Medical Affairs (12-month Fixed Te
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in compliance and governance. Use keywords from the job description to show that you understand what we're looking for.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills, like attention to detail and procedural document writing, have made a difference in your previous roles. We want to see real examples!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and make sure your key achievements stand out.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the quickest way for us to receive your details and get the ball rolling on your journey with us!
How to prepare for a job interview at Merck & Co., Inc.
✨Know Your Stuff
Make sure you brush up on the ABPI Code of Practice and UK regulations. Being able to discuss these confidently will show that you’re not just familiar with the rules, but that you can apply them in real-world scenarios.
✨Showcase Your Writing Skills
Since you'll be authoring medical quality documents, prepare examples of your previous work. Bring along a couple of SOPs or policies you've written to demonstrate your attention to detail and procedural writing experience.
✨Prepare for Scenario Questions
Expect questions about how you would handle compliance challenges or ambiguous situations. Think through some past experiences where you had to make tough decisions and be ready to share those stories.
✨Emphasise Collaboration
This role involves working cross-functionally, so be prepared to discuss how you’ve successfully collaborated with different teams in the past. Highlight any specific projects where teamwork led to successful outcomes.
