Job Description

Manager Medical Writing

This position involves managing the performance and workload of Medical Writers, including short-term and long-term resource planning to assign projects appropriately.

Responsibilities include supervising the preparation of deliverables, organizing processes to meet timelines, and evaluating the timeliness and quality of work. The role includes assisting writers with data presentation and interpretation, performing peer reviews for adherence to standards, participating in SOP and WPD preparation and review, and evaluating compliance.

Key Responsibilities:

Supervises Medical Writers Train writers and assess their output Supports short-term and long-term resource planning to assign projects to appropriate and available staff Assists staff with forecast project-related costs and timelines for completion. Supports hiring and evaluation of new employees. Supervises Medical Writing deliverables. Evaluates timeliness and quality of deliverables and provides updates to senior management. Performs peer review to ensure overall adherence to departmental standards. Stays updated on the guidelines and requirements of the ICH, FDA and other relevant agencies. Gives marketing presentations to potential clients on the capabilities of Medical Writing Uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data.

Education and Experience:

Bachelor's degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience. 8 years' relevant experience in regulatory medical writing. 2+ year of leadership (team management) responsibility; longer tenure would be preferable.
Job Types: Full-time, Permanent, Freelance

Pay: ₹35,000.00 - ₹60,000.00 per month

Work Location: In person