Job Details
Senior Document Quality Reviewer
Company: Hays Pharma
Location:
Reference: AG3252
Closing Date: 16 Aug 10
Type: Contract
Salary: On Application
Benefits: 4 Days per Week
Job Summary:
My Client is a Leading Global Biotech who require an accomplished Medical Writer to join their team in a supportive role on a contractual basis.
Requirements:
Responsible for performing editing review and providing quality control to documents written by Medical Writers in multiple therapeutic areas.
Performs technical editing to ensure consistency across related documents, as well as grammatical and stylistic consistency.
Provides medical and scientific content editing of regulatory documents.
Performs number and consistency checking of data within documents.
Works with Medical Writers to resolve inconsistencies. Actively improve clinical documentation and templates developed by Medical Writing.
Documents include IND Annual Reports, Protocols and Protocol Amendments, Model Patient Informed Consent Forms (ICF), Patient Safety Information for ICF, Investigator’s Brochures (includes Development Core Safety Information [DCSI]), Clinical Study Reports, and Patient Safety narratives.
Review sections of Clinical Trial Applications, License Applications, Package Inserts, Abstracts, Posters, Presentations, and other regulatory documents.
Provides expert review of all clinical documents produced by Medical Writing for grammar, format, clarity and adherence to template and style guide.
• Ensures Medical Writing documents meet expected Document Quality guidelines at time of review
• Ensures Medical Writing documents are compliant with document templates
• Bachelor’s degree required in English, Journalism, or related fields with background or related work experience in scientific or medical fields
• Computer skills: thorough comprehension of Microsoft Word, Excel, database entry, Lotus Notes
• Ability to prioritize, coordinate, and complete multiple complex projects within given timeframes
• Ability to work well under pressure
• Excellent oral communication and interpersonal skills; fosters teamwork
• Writing and/or editing experience or training required (BELS certification preferred)
• Experience in clinical trials and regulatory documents strongly preferred
To apply for this position please send your CV in the strictest confidence to:
However, if you wish to discuss this opportunity or want to discuss other roles that we are working on, do not hesitate to contact Anna Graham (Medical Information Recruitment Specialist) on 0207 633 4835.
About us:
Hays Pharma are an international Search & Selection firm providing resourcing solutions to the pharmaceutical industry. We have a proven track record recruiting within the Regulatory Affairs market & have a dedicated team appointed to this function. Having established relationships with the worlds leading companies in Biotech, Pharmaceutical, Devices, Clinical Research & Consulting we are ideally placed to find our candidates their next permanent or contract position in Medical Information. As members of REC we comply fully with all EAA legislation governing the employment industry.
Key words, Medical Information, Medical Communications, Medical Writing, Editor, MI, Medical, Affairs, Scientific Liaison, Medical Liaison, Medical Communications specialist, Medical Science Manager, Medial Services, Executive, officer, manager, Director
Contact Information:
| Address: |
Head Office Hays Pharma Ltd 25-27 Wootton Street London SE1 8TG England |
|
|---|---|---|
| Tel: | Tel: +44 (0) 207 922 7100 | |
| Fax: | Fax: +44 (0) 207 922 7101 |
Hays Pharma is a trading division of Hays PLC and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C’s, Privacy Policy and Disclaimers which can be found at hays.com
