Senior Medical Writer

Proclinical is working with a swiss-based pharmaceutical company that is seeking urgently a Senior Medical Writer to be based in France on a permanent basis. This pharma company is looking for candidates willing to relocate from mainly within France but anywhere is Europe is also an attractive option. This Senior Medical Writer role will be joining the company's Clinical Research and Development department.

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 finalisation/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.

Job 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.

Skills and Requirements:

• Experienced in writing protocols/amendments, briefing books, Health Authority responses, 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 (understandable, 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 organisation.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call George Watson on + 13368428682 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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