Senior Medical and Promotional Compliance Officer

Aspen Pharma Group; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Aspen Pharma Group in Ireland seeks an experienced Medical Affairs and Compliance professional to provide scientific and promotional compliance support for the Aspen EME portfolio. You will ensure communications are accurate, balanced, evidence-based and aligned with Aspen policies and industry standards.

The role covers review and approval of materials via Veeva Promomats, acting as Central and Local Medical Approver, sponsorship oversight, audits, CAPAs and training across the EME region.

Qualifications

• Bachelor’s or Postgraduate degree in science, pharmacy or medicine.
• Minimum of 2 years’ experience in Medical Affairs and/or Compliance function.

Responsibilities

• Provide scientific and promotional compliance subject matter expertise for Marketing and Medical functions.
• Review and approve educational and promotional materials through Veeva Promomats or other platforms, ensuring regulatory standards and Aspen policies are met.
• Act as Central Medical Approver for materials from the Central EME team.
• Act as Local Medical Approver for materials from local EME markets where required.
• Review Aspen EME Sponsorship Committee sponsorships and meetings for compliance.
• Escalate non-compliance observations to line manager.
• Support audits and inspections, providing requested documents in a timely manner.
• Generate CAPAs with SME input for local EME markets as needed.
• Provide copy writing support to marketing for SOPs and WIs.
• Support QMS document management and change controls.
• Assist with self-inspections and training across the region.
• Develop and maintain cross-functional relationships with marketing, commercial and key stakeholders.

Skills

Promotional compliance

Medical affairs

Stakeholder engagement

Regulatory documentation

Education

Bachelor’s or Postgraduate degree in science, pharmacy or medicine

Tools

Veeva Promomats

Job description

Role Purpose

To provide promotional compliance and medical scientific support for Aspen EME existing portfolio in alignment with the organisational strategy and as per Aspen Policy for Product Promotion & Scientific Engagement, Aspen Policies and Procedures and industry standards.

To provide promotional compliance and medical scientific support for Aspen EME existing portfolio in alignment with the organisational strategy and as per Aspen Policy for Product Promotion & Scientific Engagement, Aspen Policies and Procedures and industry standards. The role's primary focus is the review and approval of promotional and educational materials, ensuring that communications are scientifically accurate, balanced, evidence-based and compliant with applicable regulations. The individual serves as both a Central and Local Medical Approver, reviewing materials through Veeva Promomats and supporting sponsorship activities, meetings and healthcare professional engagements. In addition to promotional compliance responsibilities, the role supports quality management activities, including document control, change controls, deviations, CAPAs and self-inspections. The position also provides training and guidance on marketing practice standards, audit readiness and compliance requirements across the EME region.

Responsibilities

Promotional & Compliance

Provides support to Pharma Affairs as a scientific and promotional compliance subject matter expert for Marketing and Medical functions.

Material Review

• Reviews and approves educational and promotional materials through Veeva Promomats or other identified platform, ensuring Aspen EME adheres to all regulatory standards and the Policy for Product Promotion & Scientific Engagement.
• Acts as the Central Medical Approver for materials generated by the Central EME team from both a medical and compliance perspective.
• Acts as the Local Medical Approver for materials generated by local EME markets from both a medical and compliance perspective (where required).

Aspen EME Sponsorship Committee

• Acts as the compliance reviewer and approver for Aspen EME Sponsorship Committee for HCP and third-party meeting sponsorships and Aspen-organised meetings and events.

Compliance Monitoring

• Escalates observations of non-compliance to line manager in a timely manner.
• Assists local EME markets during internal and external audits and/or inspections and ensures that relevant document requested by auditors are provided in a timely manner.
• Provides SME support to local EME markets in generating appropriate CAPAs, where necessary.

Medical affairs

• Provides copy writing support to the marketing department for drafting and periodic review of standard operation procedures (SOPs), work instructions (WIs) etc.

Quality Management System

• Support the document management of marketing procedures under Quality Management System (QMS).
• Supports with maintenance of the QMS by raising change controls, deviations CAPAs, as appropriate.
• Supports line manager during self-inspections.

Training

• Provides Marketing Practice training and ongoing support to Aspen EME colleagues.
• Completes assigned job training in a timely manner.

Personnel

• Develops and maintains working relationships with marketing and commercial colleagues and with key stakeholders in Aspen EME to enhance cross-functional teamwork and success.

Other

• Review of supporting documentation for commercially driven-Organized Data Collections System programs for the region.
• Maintains relevant records as soft copy and hard copies, if required as per Aspen EME filing structure/instruction.
• Adheres to Company Health & Safety procedures.
• Completes any other duties as assigned by line manager.

Bachelor’s or Post Graduate degree in science, pharmacy or medicine

Minimum of 2 years’ experience in Medical Affairs and/or Compliance function.

Working with remote team is considered as an advantage.

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