Final Medical Signatory at SCIRIS · Various

About Indigo Medical Indigo Medical provides outsourced medical compliance support to pharmaceutical clients at UK, European and global levels, spanning factual accuracy review and final medical signatory certification across multiple therapy areas.

Role purpose To review and certify promotional and non promotional materials in line with ABPI/PMCPA, EFPIA/IPHA and relevant local regulations, ensuring scientific accuracy, compliant interpretation of data and timely approvals that enable effective brand and medical activities.

Key responsibilities

Compliance review & certification

• Act as Nominated/Final Medical Signatory for UK and ex UK materials, ensuring full compliance with applicable global and local regulations, codes and case law.
• Reliably apply the codes and company procedures to materials and situations; identify clear and obvious breaches and pick up potential breaches, escalating appropriately.
• Exercise sound judgement in grey areas, identifying risks and proposing pragmatic, compliant solutions.
• Draft and manage regulatory correspondence, including letters of complaint/defence to authorities and inter company dialogue, to successful resolution.

Scientific & strategic input

• Critically appraise published clinical data; challenge claims, references and data interpretation; reliably spot inaccuracies and errors in materials.
• Provide brand and campaign concept review, demonstrating a strong understanding of strategic marketing and medical processes.
• Work confidently across multiple therapy areas, switching quickly into new disease areas as required. Ways of working
• Maintain very good time and workload management, meeting service levels and ensuring predictable turnaround times.
• Negotiate effectively (internally and externally) to align on compliant outcomes and timelines; manage broad client relationships professionally.
• Coach and mentor colleagues (accuracy reviewers, junior signatories), role modelling high standards and sharing best practice.

Experience & competencies (what you’ll bring)

Technical compliance & judgement

• Detailed knowledge of relevant global and local regulations, codes and case law (e.g., ABPI/PMCPA, EFPIA/IPHA) and a proven ability to apply them reliably.
• Breadth of material types (digital, meetings, training, press, disease awareness, HCP/public materials etc.) with a track record of:
  • spotting clear breaches and potential issues;
  • risk assessing grey areas and offering compliant alternatives;
  • accurate, defensible data interpretation in copy review.

Scientific & commercial acumen

• Strong capability to critically appraise clinical evidence and ensure accurate, balanced, substantiated claims.
• Good understanding of strategic marketing and medical processes; competent in brand/campaign concept review.

Stakeholder & personal effectiveness

• Very good time/workload management across multiple brands and therapy areas.
• Experienced negotiator with broad client relationship exposure (brand, medical, compliance, agencies).
• Demonstrated coaching/mentoring of colleagues.

Qualifications & eligibility

• UK registered Pharmacist (GPhC) or Physician (GMC), eligible to act as Nominated/Final Medical Signatory under the ABPI Code.
• Prior experience as a Final/Nominated Signatory in pharma/agency is essential; strong senior accuracy reviewers on a signatory pathway will be considered if they fully meet the competency profile above.

Measures of success

• Right first time certification and on time delivery against agreed SLAs.
• Demonstrable risk identification and pragmatic, compliant solutions in complex/ambiguous cases.
• Quality of scientific critique (data accuracy, substantiation).
• Positive stakeholder feedback and evidence of coaching impact within the compliance team.

Right to Work We have a legal obligation to ensure that all our employees have the right to work in the UK. If we make an offer of employment, we will need to check that you are eligible to work in the UK before you start.

Working Conditions

This is a hybrid role, with an expectation to work in the office at least three days per week. The role is based in Bletchley, Milton Keynes.

Salary

£65,000 – £85,000, depending on experience.

Benefits

What We Offer – From Day One:

• 5% Employer pension contribution scheme with salary sacrifice option
• Cycle to work scheme
• Income protection & life assurance
• 24/7 Employee Assistance Programme (EAP)
• Annual flu jab & eye test
• Access to wellbeing apps
• 25 days annual leave + UK bank holidays

After Probation:

• Private medical insurance
• Long service rewards: o Extra day of annual leave each year after 3 years o Monetary recognition at 5, 10 & 15 years