Document Review Specialist (EMEA)

Job title : Document Review Specialist (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 Document Review Specialist to join them in their friendly, fast paced, professional team.

Client: Global CRO
Duration: 6 Months (possibility of extension to 12 Months)
Location: Remote - Able to travel to Ghent area as necessary
Rate: Negotiable based on experience

The Document Review Specialist will ensure that documents generated both internally and externally are of a sufficiently high standard so as to meet the requirements of the client.

As a Document Review Specialist, you will:
* Review documents including regulatory submissions, integrated clinical study reports,
serious adverse event narratives, study protocols and publications
* Ensure the integrity of data in tables against source documents.
* Instruct others outside of the quality review group on the review process

Essential duties and responsibilities (include but not limited to):
* Review highly technical documents of all types created inside or outside of the company
* Verify scientific logic and clarity of the document by verifying data in tables
* Edit for accuracy, consistency and grammatical correctness
* Adjusts schedule to accommodate unexpected requests for priority review.
* Revises scientific language for usage, flow, clarity, and audience appropriateness.
* Proactively queries authors
* Maintains, communicates and applies knowledge of current guidelines, templates and industry standards

Skills/experience required:
* Able to concentrate on the details of a document without losing sight of the overall
objectives and intent of the document's message
* Good knowledge of the methods, techniques, and procedures of medical writing tasks
* Strong analytical ability
* Good working knowledge of medical terminology, statistical concepts, GCP, guidelines
(e.g., ICH), and requirement of the FDA and other international regulatory agencies
* Detail oriented, thorough and methodical
* Full business proficiency in both English and Dutch
* Proficient grammatical and communication skills, both oral and written
* Good organizational and planning skills
* Proven ability to work effectively in a team environment
* Advanced computer literacy and expertise
* Good understanding of document management systems
* Capable of working well under pressure and remaining motivated
* Capable of working both independently and collaboratively with a team in a cross-cultural,
geographically dispersed environment

If you are interested in applying for this role, send your CV to Jayne.Stiff@secpharma.com or give me a call on +44(0)207 255 6630 to discuss this further.