Process Development and Operations Manager in Medical Affairs

Be the new Process Development and Operations Manager in Medical Affairs

In a biotech company bonding to discover, design and develop innovative peptide-based medicines

Do you have a strong eye for details, a passion for structured processes, and experience in Medical Affairs compliance? We are currently seeking a highly organized and detail-oriented professional with strong administrative skills to support and strengthen key Medical Affairs initiatives, processes and ensure global compliance standards are met. If this sounds like you, and you are ready to take on a broad area of responsibilities with a proactive attitude, you are a match for us.​

This is an exciting opportunity to work in a collaborative, international environment where your contributions will directly support Medical Affairs Operations and patient-focused initiatives across the globe. The growth and ambition of Zealand Pharma provides exciting long-term development opportunities.

About the Role:

As a Process Development and Operations Manager in Medical Affairs, you will play an important part in developing processes and ways of working in a growing Medical Affairs team.

You will be instrumental in building the functional capabilities and optimizing the way we work, making sure Zealand Pharma, external collaborators and patients are served by a partner of the highest quality.

In addition to developing our processes, you will be responsible for compliance monitoring supporting the Medical Affairs function and thereby contributing to ensuring that Zealand Pharma adheres to all applicable laws, regulations, and industry standards. You will work closely with colleagues across Medical Affairs and related functions, including Regulatory, Legal, and Compliance, to help maintain high operational standards and ensure process consistency.

Ideally you have a flair and interest in driving process development and implementation of new technology to assist efficiency across the organization. This could be an opportunity to contribute with AI project developments and implementation.

Responsibilities:

• Drive and contribute to Medical Affairs process improvement initiatives, from planning through implementation, helping to identify opportunities for process improvement and operational efficiency.
• Collaborate with cross-functional stakeholders to gather input and ensure clear, practical processes for key Medical Affairs activities (e.g., medical review, scientific engagement, training and medical education).
• Coordinate and provide administrative support for Medical Affairs compliance activities and ensure alignment with internal policies and external standards (e.g., FDA, EFPIA, IFPMA).
• Support and drive the creation, review, and updates of standard operating procedures (SOPs), work instructions, and process documentation for Medical Affairs.
• Drive the development and management of governance frameworks and documentation libraries.
• CRM system experience, including Veeva, is an advantage.
• Monitoring performance metrics and compliance indicators, supporting internal reporting and audits as needed.
• Track and support the implementation of global and local compliance requirements and process controls.
• Assist in developing and delivering training for Medical Affairs colleagues as needed.

Candidate profile:

• Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree a plus).
• 3+ years of experience in Medical Affairs, Compliance, Quality Assurance, or a related area in the pharmaceutical or biotech industry. A wider experience from Medical Affairs is beneficial.
• Solid understanding of medical compliance frameworks and industry codes.
• Experience from working with US Medical Affairs compliance is strongly preferred.
• Strong written and verbal communication skills, with high attention to detail and strong organizational abilities.
• Fluent in verbal and written English as English is our corporate language
  Experience from process development across a matrix organization.
• Experience with SOP development, documentation processes, or project coordination.
• Comfortable working in a global, matrixed organization with multiple stakeholders.
• AI-implementation experience is an advantage.