Manager/Sr Manager Medical Writing, Marc Nichols Associates, Inc.
Full Time, New York, New York
Manager/Sr Manager Medical Writing
The major functions to be performed in this position are as follows:
- Manage work assignments for approximately five medical writers comprised of a FTE contract on-site and contract off-site so that work is performed within established timelines.
- Assure compliance with ICH guidelines and adherence to established templates.
- Provide ongoing training in Progenics style and document formats.
- Provide leadership to medical writers to develop this functional area into a cohesive professional organization.
Seven to ten years of experience for a manager; ten years of experience for a senior manager. Experience in clinical indications of oncology, GI and HIV are preferred. Experience with Regulatory filings- NDA a must. Experience with eCTD filings preferred. Experience with managing budgets for functional writing group is preferred. Demonstrated mature and effective supervisory and management skills. Ability to complete projects within established timelines. Technical skills: Expert in MS Word, Excel, Adobe functions, conversion of SAS to MS Word. Mastery in the use of templates for protocols and CSRs.
Contact Jerry Frank, email@example.com 212 812 1146