Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Clinical Research & Development department based in Lausanne we are looking for a
The Medical Writer develops study protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs) and Investigator's Brochures (IBs) ensuring compliance with international requirements and manages the process of reviews, reconciliation of comments and document finalization/approval.
The Medical Writer works towards the timely development of these documents in agreement with deadlines set together with the Study Team and the Medical Director.
Your main responsibilities
- Author and/or update clinical study protocols/amendments, ICFs, CSRs and IBs, as required for each individual project; the documents should be accurate, suited for the intended audience and easy to read. 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 company procedures and quality standards.
- Experienced in writing protocols/amendments, briefing books, Health Authority re-sponses, IBs, CSRs, ICFs.
- Self-starter, flexible, able to adapt quickly in a fast-moving environment.
- Ability to understand the purpose and requirements of a project.
- Good command of the English language and solid writing/editorial skills (understanda-ble, at a level appropriate to the audience and the project).
- Knowledge of science or an aptitude for understanding it, including the ability to learn new therapeutic areas quickly. Familiarity with medical terminology.
- Ability to interpret and present data in a logical manner.
- Ability to work within team, as well as independently.
- Good time management skills and able to meet deadlines.
- Attention to detail, accuracy, and logical organization.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- 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.
If you fit this profile please send your application using this form.
For more information : www.debiopharm.com