Medical/Scientific writer (special consultant)

The Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW, based at the Faculty of Health and Medical Sciences, University of Copenhagen is looking for a medical/scientific writer to support the development of a cutting-edge stem cell therapy for treatment of ulcerative colitis. The medical/scientific writer will work closely with the team of Professor Kim B. Jensen at reNEW, Copenhagen.

We are seeking a talented co-worker starting March 2024 or as soon as possible thereafter for an initial 3-year period.

reNEW
The Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW, , is an international consortium of three leading research institutions in the University of Copenhagen, Denmark, Murdoch Children’s Research Institute in Melbourne, Australia, and Leiden University Medical Center in Leiden, The Netherlands. The Mission of reNEW is to bring together research excellence to harness the therapeutic potential in stem cell medicine. For this, researchers within reNEW address fundamental questions in stem cell and developmental biology and aim to translate research findings to products that will help patients with incurable disorders such as congenital kidney disorders, chronic ulcerative disorders, neurological disorders, diabetes, bladder defects and chronic pulmonary conditions, and fertility and liver disorders.

The Jensen Team is looking for a medical/scientific writer, who will assist us to move a cellular product towards a clinical trial. To move this work forward towards a clinical trial, you will serve as an expert medical/scientific writer, responsible for planning, developing, and writing clinical documents to support medical and regulatory activities. Ideally, you will have an academic degree in life sciences and solid knowledge of regulatory requirements.

Key activities

• Prepare, write and edit clear, concise text for regulatory medical documents.
• Plan, develop and finalize clinical documents for submission to regulatory authorities, including briefing documents, investigator’s brochures, and study protocols.
• Interact with an expert research team to optimize clinical documents.
• Ensure documents adhere to Danish and European Medical Agencies or other regulatory guidelines.
• Stakeholder relationship coordination and liaison with medical authorities.
• Professional discretion and an ability to maintain high levels of confidentiality.

Selection Criteria

• An advanced degree in a relevant field such as stem cell biology, biotechnology regenerative medicine or a related discipline and/or relevant experience in a similar role in regulatory medical writing.
• Familiarity with relevant regulatory guidelines around ATMPs and ethical considerations in the field will be advantageous.
• Prior knowledge on regulatory requirements around Advanced Therapy Medicinal Products (ATMPs) and the regulatory landscape related to stem cell therapy, including EMA regulations will be advantageous.
• Proficiency in writing and editing scientific and medical documents, including research papers, regulatory submissions, clinical protocols, and informed consent forms.
• Well-developed communication skills (written, oral and interpersonal) and the ability to liaise effectively with cross-functional teams, including scientists, clinicians, regulatory experts, and project managers.
• Capacity to write clear, concise medical regulatory documents.
• Ability to think strategically and independently in order to forward plan and monitor future priorities.
• Excellent organizational skills with the ability to multi-task and work independently to plan, coordinate and organize projects.
• Adherence to ethical standards in medical research and a commitment to data integrity and patient safety.
• A sound knowledge of Microsoft Office suite.
• Ability to handle and uphold confidentiality with maturity and common sense.
• Experience in adhering to specific style guides and industry standards (e.g., ICH, GCP, or CONSORT).
• Insight into the clinical trial process, including protocol development, patient recruitment, data analysis, and reporting will be an advantage.
• Ability to think strategically and independently in order to forward plan and monitor future priorities.
• Meticulous proofreading and editing skills to ensure accuracy in all written materials.
• Ability to review and interpret complex data and translate it into understandable content for various audiences.

You will be part of a thriving center with innovative researchers and administrative staff.

Place of employment
The place of employment is at node of reNEW, Blegdamsvej 3b, University of Copenhagen. We offer creative and stimulating working conditions in dynamic and international research environment and will report directly to Professor Kim B. Jensen.

Terms of employment
The position is a fixed-term position limited to a period of 3 years. The starting date is 1 March or after agreement.

Working hours are negotiable to accommodate potential additional roles but will be up to 37 hours per week incl. lunch.

Salary and employment depend on your background under the Organization Agreement AC (special consultant/fuldmægtig) and the Ministry of Finance with the possibility of negotiating supplements depending on seniority, qualifications and competencies.

Questions
For further information regarding the position, please contact Kim B. Jensen, [email protected]

Application
Your application should be in English include:

• Letter of application addressing the requirements (max. one page).
• Curriculum Vitae
• A certified/signed copy of certificate(s) of education

Please submit your application by clicking on “Apply Now” below. Only online applications will be accepted.

Application deadline: 16 January, 23.59 CET

We reserve the right not to consider material received after the deadline, and not to consider applications that do not live up to the abovementioned requirements.

Interviews are expected to be carried out in the first half of January 2024.

More information
You can read more about reNEW at http://renew.ku.dk

We look forward to receiving your application with CV and documentation for education via the job site https://employment.ku.dk/staff/

UCPH is currently designing a new administrative organisation. It is expected this new organisation will cause changes during the next year and a half. One of the goals with the new organisation is to stregthen the cooperation across UCPH, and to increase the effectiveness and secure excellent career paths for the administrative staff at UCPH. Please contact Kim Bak Jensen for information regarding the link between this position and the new organisation.

We want to reflect the surrounding community and therefore encourage everyone, regardless of personal background, to apply for the position.

Part of the International Alliance of Research Universities (IARU), and among Europe’s top-ranking universities, the University of Copenhagen promotes research and teaching of the highest international standard. Rich in tradition and modern in outlook, the University gives students and staff the opportunity to cultivate their talent in an ambitious and informal environment. An effective organisation – with good working conditions and a collaborative work culture – creates the ideal framework for a successful academic career.