Principle Medical Writer - EMEA

Job title : Principle Medical Writer - EMEA
Location : Ghent, East Flanders
Job type : Contract/Freelance
Salary : Negotiable
Contact name : Jayne Stiff
Contact email : jayne.stiff@secpharma.com

A global CRO is looking for an experienced Principal Medical Writer to join them in their friendly, fast paced, professional team.

Client: Global CRO
Location: Remote - Must live in Belgium/Netherlands
Duration: 6 months minimum (will probably extend to 12 Months)
Rate: To be discussed based on experience

The Principal Medical Writer will provide high quality medical and scientific writing from planning to the delivery of final drafts.

As a Principal Medical Writer, you will:
Review documents for the team and provide training and guidance to junior team members.

The Principal medical Writer will:
-Review documents for the team and provide training and guidance to junior team members.
-Provide advice on document development strategy
-Demonstrate subject matter and therapeutic area expertise
-Collaborate with internal and external clients
-Deliver operational excellence

Responsibilities (include but not limited to):
-Research, write and edit clinical study reports and study protocols
-Serve as primary author on complex clinical, scientific and program level documents, including IBs, INDs, and MAAs
-Provide senior level reviews on routine and complex documents
-Ensure compliance with quality processes and requirements for assigned documents
-Serve as a backup program manager if required
-Represent the department

Skills/experience required:
-Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
-Advanced degree preferred
-Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to a minimum of 8 years)
-Experience in managing and directing complex medical writing projects is essential
-Experience working in the pharmaceutical/CRO industry preferred
-Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
-Significant knowledge of global, regional, national and other document development guidelines
-In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
-Strong communicator
-Fluent in written and verbal English and Dutch
-Able to travel to Ghent as required