Manager, Medical Writing

Manager, Medical Writing

The Manager, Medical Writing is responsible for leading medical writing projects pertaining to clinical drug development in an assigned therapeutic area.  Will manage the preparation of high-quality clinical documents (e.g., clinical study reports, briefing books, integrated summaries) in compliance with regulatory requirements and company style/format.  Will participate as an active member of clinical study teams and works in collaboration with cross-functional areas.  Responsibilities of this position are to manage the work of clinical medical writers (both internal and external).  Prepare, edit and review clinical documents as lead clinical writer in assigned therapeutic area.  Work in collaboration with Clinical Development, Drug Safety Surveillance, Clinical Data Management, Biometrics (Biostatistics and Statistical Programming), Clinical Pharmacology and Drug Dynamics, Regulatory Affairs, and Project Management.  Prepare high-quality clinical documents including clinical study reports, briefing books, and integrated summaries of global regulatory submissions.  Edit and review documents for organization, clarity, use of the English language/grammar, consistency, and scientific standards.  Resolve errors and inconsistencies in clinical data with appropriate project/study team members.  Adhere to Medical Writing processes for quality document preparation, document review, accurate comment solution/incorporation, and document finalization.  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.  Successful candidate shall be required to contribute to scientific/technical and medical writing reviews of documents (e.g., Statistical Analysis Plan) for Biometrics, as needed.  Update clinical study and global regulatory submission document templates, as needed.  A Master's Degree or equivalent required; PhD preferred.  10+ 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 data and synthesize data.  Professional leadership ability.  Working knowledge of document management system (e.g., Documentum®).  Proficient in Microsoft Office applications.

Please refer to job code TP6452 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Operations
Location:	West New York, NJ
County:	Hudson County
ZIP Code:	07093
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856