Life Scientist - Medical Writing, Clinical Research (m/f/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:
The Medical Writer will be responsible to write a range of clinical documents from initiation to completion, producing high-quality, clear and accurate work. She/he will also be required to contribute to document quality control (reviewing data accuracy, formatting and appropriateness of language, and compliance to industry guidelines) as well as evaluate the data to be included within documentation.

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

Medical Writer (f/m/d)

Your Role:

• Write clear and concise clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, product labels (US PI, EU SmPC, CCDS), study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, risk management plans and integrated summaries of safety and efficacy
• Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers
• Perform literature-based research to support writing activities
• Support project teams by providing scientific and medical writing consultancy on various aspects, as requested (Renewals, Benefit/risk assessment, Independent Data Safety Monitoring Boards reports, etc.)
• Provide medical and editing review of draft and final documents prepared by other writers before internal or external distribution
• Work in coordination and closed interaction with Global Medical Leads/Medical Experts, Safety Leads and Regulatory Leads within the organisation
• Organize and lead document development/review meetings
• Keep oversight of documents outsourced to other medical writing CROs
• Develop and ensure adherence to clinical and regulatory writing timelines, standards, and processes
• Response to query for medical expertise

What we are looking for:

• At least 4 years’ experience in a similar role
• Advanced degree in life sciences or relevant scientific/clinical/regulatory field
• Good experience in any complex diseases, oncology experience is preferred
• Ability to understand and interpret clinical and scientific data, and present results in an understandable manner to a variety of audiences
• Excellent command of the English language, both verbal and written communication skills
• Demonstrate keen attention to detail and faultless grammar and spelling
• Strong problem solving, analytical, organizational, good project and time management skills with proven ability to follow briefs and meet deadlines
• Team player who quickly creates positive and productive working relationships
• Experience in interventional trials
• Ability to prioritize multiple projects

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