SENIOR MEDICAL WRITER

Job Description

A Senior Medical Writer prepares and reviews clinical regulatory documents. Further responsibilities include: communication with clients for medical writing projects, meet timelines, leadership, and training and support of junior medical writers.

Duties and Responsibilities 

• Writing clinical documents for submission
• Reviewing of draft and final documents prepared by other writers before distribution
• Ensure that content and style of documents adheres to regulatory guidelines and complies with client SOPs and guidelines
• Attend client team meetings and internal meetings related to the medical writing project
• Provide training and guidance to junior medical writers
• Keep ahead of information and technology through workshops and conferences and transfer the information to other team members

Qualifications

University degree (MSc or PhD from a reputable university) in a biomedical or related discipline and at least 5 years experience as a Clinical Medical Writer at a pharmaceutical company or international contract research organization. 

Job Requirements

• Fluent English (oral and written) and familiar with medical and scientific terminology
• Excellent in scientific interpretation/presentation of data and understanding of biostatistics
• Broad knowledge of FDA en EMA guidelines
• Eye for details
• Good computer skills, especially Microsoft Office
• Good communication and organizational skills, and stress resistant
• Ability to work independently and in the study team, be able to manage multiple tasks
• Client focused approach, professional attitude
• Teamleadership & positive team-oriented attitude
• Own car and legal drivers license

In return...

 ...EMTEX offers a competitive compensation, with a comprehensive benefits plan in a supportive and rewarding environment.

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Contact Information

Interested? Please send your application letter with an indication of your motivation and experience together with your CV to mario.de.witte@emtex.be or by mail to EMTEX BVBA - Mario De Witte - Heistraat 99 - 9190 Stekene.