Life Scientist - Lead, Medical Writing, Regulatory Affairs (m/w/d)

Beschreibung

ITM Oncologics GmbH (ITM)

ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).

Job Summary
In his/her position the Senior Medical Writer will write, review and control the quality of clinical, medical, regulatory and pharmacovigilance documents working closely with external sub-contractors (CROs) and ITM internal departments (Regulatory Affairs, Safety and Pharmacovigilance, Clinical Development, R&D and Global Medical Affairs).

Furthermore, the role will also focus on growing and mentoring a team of medical writers at ITM. Proven previous experience in managing direct reports will be preferred.

We would like to fill the following vacancy as soon as possible:

Senior Medical Writer / Team Lead (f/m/d)

Your Role:

• Write and review high quality clinical, medical, regulatory and pharmacovigilance documents such as IDSMB reports, DSURs, RMPs, Study Protocols, ICFs, CSRs, IBs, Paediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, responses to Health Authorities, as well as Abstracts, Posters, Editorials, Slide decks and other Publications
• Ensure document quality check performed prior to release every version (draft and final)
• Develop and maintain processes, guidelines and templates enabling high-quality document production
• Lead, monitor, and supervise a group of medical writers to achieve goals that contribute to ITM’s organizational development

What we are looking for:

• Life science degree
• Minimum 7 years of professional medical writing experience in drug/biologic developing company, ideally in oncology indication
• Fluency in English and solid writing/editorial skills
• Strong knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical, medical, regulatory and pharmacovigilance documents
• Strong working knowledge of the clinical drug development process, clinical trial design and biostatistics
• Strong experience integrating information into clinical, medical, regulatory and pharmacovigilance documents
• Proven experience with global drug regulatory submissions, ideally with MAA/NDA
• Ability to work in a hierarchically flat, matrix environment
• Good management, interpersonal, communication, negotiation and problem solving skills

What we offer:

• A modern workplace and exciting opportunities in an evolving and fast growing company
• Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
• A collegial corporate culture and short communication channels
• Flexible working hours with an attractive salary package, diverse corporate benefits and home office possibilities