Senior Medical Writer
The Senior Medical Writer develops study protocols and amendments, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs) and other regulatory documents for our Oncology programs, ensuring compliance with international requirements. He/she manages the process of reviews, reconciliation of comments, document finalisation and approval.
The Medical Writer works towards the timely development of these documents in agreement with deadlines set together with the Study Team, the Medical Director and the Regulatory Affairs Department.
Your Main responsibilities:
- Author clinical and regulatory documents such as study protocols and amendments, ICFs, CSRs, IBs, Pediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to health authorities; the documents should be accurate, suited for the intended audience and easy to read.
- Be responsible for triggering annual IB reviews and potential updates.
- Collaborate closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review process, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline.
- Ensure understanding and implementation of international quality standards (ICH GCP) and internal company procedures.
- Facilitate document review meetings and discussions.
- Contribute to the development of project timelines.
- 3-5 year of experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
- Experience in early phase clinical development in Oncology.
- In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
- Working knowledge of the clinical drug development process, clinical trials design and biostatistics, with experience in integrating information into clinical-regulatory documents.
- Fluency in English and solid writing/editorial skills (understandable, at a level appropriate to the audience and the project).
- Experience with effectively managing vendors and contract writers to meet timelines/project objectives.
- Ability to work within team, as well as independently.
- Strong ability to prioritize and manage multiple demands and projects.
- Expertise in MS Word. Ability to interpret and present data in a logical manner.
- Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.
- Good time management skills and able to meet deadlines.
- Attention to detail, accuracy, and logical organisation. Expertise grammatical and communication skills, both written and oral.
- Knowledge of science or an aptitude for understanding it, including the ability to learn new therapeutic areas quickly. Familiarity with medical terminology.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- A competitive salary package.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.