Be our new Senior Process and Compliance Manager, Clinical Oversight & Compliance
Are you ready to make a significant impact within Clinical Oversight and Compliance? If so, join our department to lead inspection readiness activities with the trial teams, and contribute to audits, while developing inspection readiness process. You will also oversee the development of SOPs and maintain robust record management, collaborating across the organization to effectively address and resolve compliance-related issues.
In your daily work, you will work closely together with our Process Manager, Clinical Trial Teams, QA GCP and collaborate both with internal departments and external service providers, including CROs. If this sounds appealing to you, and you are ready to take on a broad area of responsibility within Inspection Readiness and compliance with an independent yet collaborative approach, you could be a match for us.
Clinical Oversight and Compliance is a newly established department within Clinical Operations. We are a group of 5 dedicated professionals specializing in sponsor oversight, clinical technologies, processes, and compliance. Our team works as one team and values an informal atmosphere with a focus on knowledge sharing and excellence.
Key Responsibilities:
- Lead inspection readiness activities in Clin Ops and be an active contributor during regulatory inspections and audits.
- Contribute to the development, implementation, and management of inspection readiness processes (SOPs, guides, checklists) while actively working with teams and providing internal support to ensure adherence to regulatory requirements.
- Support teams in responding to inspection and audit observations
- Enhance and maintain record management adhering to regulatory and company standards.
- Oversee the development and maintenance of Standard Operating Procedures (SOPs) and other compliance documentation.
- Collaborate with cross-functional teams to address and resolve compliance-related issues efficiently.
- Provide support to ensure timely and accurate disclosure of clinical trial information on CTIS and ClinicalTrials.gov.
Candidate Profile:
- Minimum bachelor’s degree in Life Sciences or a related field
- Minimum 5 years of experience in a similar role within the biotech or pharmaceutical industry.
- In-depth knowledge of clinical trial regulations and guidelines, including ICH-GCP, FDA, and EMA requirements.
- Experience in clinical record management
- Preferable experience in managing CTIS & ClinicalTrials.gov submissions.
- Strong analytical and problem-solving skills, with a strategic mindset.
- Excellent communication and interpersonal skills, with the ability to foster collaboration across departments.
- Detail-oriented with robust project management capabilities.
Bonding to innovate
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities
To find out more about working at Zealand, visit https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than September 21, 2025, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Helle Maach-Møller, Head of Clinical Oversight and Compliance on hmaachmoller@zealandpharma.com or +45 5060 3687
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com.
