Manager of Medical Writing Job in Job location not provided
MANAGER OF MEDICAL WRITINGSummaryResponsible for leading medical writing projects pertaining to clinical drug development in an assigned therapeutic area.
Manage the preparation of clinical documents reports and briefing in compliance with regulatory requirements.
Participate as an active member of clinical study teams and work in collaboration with cross-functional areas.Responsibilities: 1. Manage the work of internal and external clinical medical writers.
2. Prepare, edit and review clinical documents.
3. Work in collaboration with Clinical Development, Drug Safety Surveillance, Clinical Data Management, Biometrics, Clinical Pharmacology and Drug Dynamics, Regulatory Affairs, and Project Management.
4. Prepare clinical documents including clinical study reports, briefing books, and integrated summaries of global regulatory submissions.
5. Edit and review documents for organization, clarity, consistency, and scientific standards.
6. Resolve errors and inconsistencies in clinical data with study team members.
7. Adhere to Medical Writing processes for quality document preparation, document review, and document finalization.
8. Participate as an active member of clinical project/study teams and maintain professional cross-functional interactions with leadership for Medical Writing in project/study meetings.
Requirements: Master's Degree or equivalent required; PhD preferred.
8 + years of relevant medical writing experience required in clinical drug development in various therapeutic areas.
Three (3) years of supervisory experience preferred.
Experience as a lead writer of clinical study documents and global regulatory submissions and manager of medical writing projects.
Excellent verbal and written communication skills.
Demonstrated ability to analyze and synthesize data.
Working knowledge of document management system.For further information about this outstanding opportunity, please email your resume as an MS Word attachment in confidence to: Lori Sin-Rossini, CSP, CPCDirector of Research & RecruitmentLife Sciences Division lorisin [at] lloydstaffing [dot] com www.lloydstaffing.comPhone: 631.777.7600 Ext: 720Fax: 631.777.7626 http://www.
linkedin.
com/in/lorisinrossini
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