- Responsible for planning, writing, and management of clinical trial reports, submission documents, and other clinical documents. Provide critical input to the analysis and interpretation of clinical data. Contribute to the development of the medical writing function within BI. - Write high-quality clinical documents in collaboration with international study and project teams. This includes planning, development of document strategies, document coordination, overseeing of timelines, and contribution to related clinical documents (e.g. study protocols, analysis plans, statistical outputs, mock documents, investigator brochures). - Ensure timeliness and quality of assigned medical writing projects, using both internal and external resources. - Develop, adhere to, and improve medical writing standards; ensure compliance. 61 Enhance cooperation with other functions and other medical writing groups. Increase awareness and understanding of medical writing and broaden the scope of the medical writing function. - Training of new colleagues.
Qualifications - Education/Degree Requirements: Doctoral Degree (PhD, MD, PharmD) or Bachelor - Major: Biology, Medicine, Pharmacy - Language skills & proficiency: Good command of English
Required capabilities (skills, experience, competencies): Excellent scientific and analytical thinking; - Basic medical knowledge; - Good understanding of statistics and pharmacokinetics; - Sound understanding of the clinical development process; - Ability to comprehend and interpret clinical data; - Ability to lead and motivate people; - Excellent communication and interpersonal skills; - Excellent writing skills; - Ability to write documents according to readers’ expectations; - Outstanding capacity to structure text and data in a clear and concise fashion; - Efficient time and project management skills; - Proficiency in word processing and presentation software.
Behaviours - Accountabilities – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions - Agility – Quickly act with an open mind to face internal and external transformation - Intrapreneurship – Together with customers, come up with innovative ideas to respond to changing markets