Competency Development Specialist in Clinical Reporting Are you passionate about clinical process development and eager to drive process transformation? Do you have a profound understanding of clinical development and an end-to-end mindset?Then you could be the one we are looking for. Join us as Competency Development Specialist and help to shape efficient, high-quality ways of working with clinical processes.Your new roleAs Competency Development Specialist, you'll take ownership of a critical process, ensuring that SOPs, templates, and guidelines meet the regulatory requirements. This is a role where process excellence meets real impact, as the process you maintain are used daily by end-users across the globe to prepare documents that are essential for initiating clinical trials and securing drug approvals.Your responsibilities will include:
Be content responsible for a process including authoring Standard Operating Procedures (SOP), guidance and templates (e.g., PI/IC forms or medical devices)Drive process changes that affect document preparation, incl. assessing emerging external requirements and their impactMaintain efficient processes globally, and capture expert input to identify improvement opportunitiesLead global competency development and training of end-usersAct as process representative during external inspections and internal auditsBuild impactful stakeholder relationships to influence and leverage the evolving clinical process landscapeYour skills & qualificationsWe're looking for someone with strong pharmaceutical experience and a passion for process excellence who can lead through influence and collaboration.You'll bring:PhD or Master´s degree in science or equivalentMinimum 5 years of experience as a medical writer, regulatory specialist, QA professional, clinical operations or similar within the pharmaceutical industryExperience working with clinical studies and regulatory requirements within drug and device clinical developmentStrong process orientation with excellent planning, coordination, and project management skillsExperience with a broad range of different medical writing tasks, including structured authoring/content reuseFluent in written and spoken English with strong communication and cultural awareness for working across global teamsIn this role it is crucial to be able to manage complex stakeholder landscapes and drive consensus through negotiation and diplomacy while also work independently on larger projects, proactively identifying problems and suggesting solutions.Your new department The position is based in the Clinical Reporting Process Excellence, Transparency, and Archiving Department in Søborg, Denmark, consisting of 13 dedicated colleagues. We share an interest in supporting our drug and device development projects with our specific areas of expertise. You will join the CR Process Excellence team that consist of 7 colleagues working on optimising processes, SOPs, and templates critical to clinical study documentation.Working at [xxxxx]Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.More informationIf you have additional questions about the position before applying, Rikke Juul Gøbel, Associate Director, on +[xxxxx]or [xxxxx] April 2026. We look forward to receiving your application.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At [xxxxx], we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 18.3.2026, men kan have været deaktiveret og genaktiveret igen.
