Medical Advisor /Medical Writer

at  Cellcolabs

ABOUT US

Cellcolabs is a biotech impact start-up on a mission to promote advanced cell therapies to improve health. Through efficient large-scale production of mesenchymal stem cells (MSCs), we make clinical trial material for research more accessible and affordable. Located at Karolinska Science Park at Campus Solna, Cellcolabs builds on over 20 years of research findings and clinical experience. Our mission is to drive the availability of MSCs by lowering their price for research and clinical use in the future. Founded and backed by some of Sweden’s foremost health and life science entrepreneurs, we are dedicated to making a meaningful impact in the field of healthcare.

QUALIFICATIONS:

• MD, MS, or PhD in a relevant field.
• Clinical experience in cell therapies, preferably but not an absolute criteria is experience in hematology or immunology.
• Experience in the pharmaceutical or biotechnology industry is highly desirable.
• Strong communication skills and the ability to work collaboratively in a multidisciplinary team environment.
• Understands and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs

ROLE OVERVIEW:

We are seeking a dedicated and experienced Medical Advisor to join our Medical Affairs team. In this role, you will play a crucial part in bridging clinical knowledge with strategic initiatives in our innovative cell therapy projects. A substantial part of the work will be as a medical writer providing medical writing expertise for multiple compounds and/or projects within a therapeutic area. As part of our team, you will also be involved in a wide range of other assignments related to our clinical trials such as but not limited to information about ongoing trials. As a successful candidate you will have an extreme sense of urgency and superior attention to detail.

KEY RESPONSIBILITIES:

• Serve as medical writing lead on complex scientific documents and publications and medical education materials as well as clinical study protocols, reports, and publications
• Providing scientific communication and medical education document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process.
• Provide literature search, meeting transcription and reports or whitepapers
• Conduct medical consultations/inform about clinical trials and provide expert clinical advice on the use of MSCs.
• Review and approve marketing materials for technical/medical/scientific accuracy to ensure compliance with regulatory standards and scientific accuracy. This includes review against listed references, where study data from a trial are summarized in the material, secure the appropriateness of messages from a medical perspective and substantiation for all claims. This also include checking the correct use of references, imagery, and figures.
• Support ongoing clinical trials by collaborating with MSCs and providing insights to enhance study design and implementation.
• Support to Principal Investigators (PIs), fostering strong relationships and facilitating effective communication.