Head of Medical Writing
Job Locations
IN
Posted Date
2 weeks ago(3/14/2023 4:27 AM)
- ID
- 2023-1901
- # of Openings
- 1
- Category
- Medical Writing
Overview
- To provide functional leadership in Medical Writing and ensuring consistent processes and excellence in providing planning, execution, and delivery of all types of scientific reports
- To recruit, train and retain a highly skilled workforce of medical writers to support clients’ projects
- To ensure that the Medical Writing function meets time, quality, and cost targets consistent with being an efficient and effective business unit
- To advise on regulatory standards and appropriate guidelines
- To maintain the resource model and assign projects to appropriate personnel
Responsibilities
- Provide leadership and strategic direction to the Medical Writing department
- To provide medical review of clinical study reports, journal manuscripts, clinical overviews, clinical summaries, and other clinical trial-related documents produced by the Company’s in-house medical writers
- To guide the in-house medical writers in the interpretation of medical data
- To write advanced level medical writing documents for clients, e.g., clinical expert reports, pre-clinical expert reports, clinical overviews, investigator brochures
- To provide medical writing consultancy services, e.g., regulatory support, medical marketing support and medical management reviews to clients on behalf of the Company
- Ensure that all activities are conducted in compliance with relevant regulatory requirements
- Have thorough understanding of ICH and other regulatory guidelines, as well as multiple therapeutic areas, the clinical development process and purpose of the regulatory documents
- Develop people, including recruitment, retention, training, and career development to ensure an effective workforce to support clients
- Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice with respect to writing activities
- Ensure that learnings are shared and applied across projects, and implant strategies to achieve continuous process improvement toward excellence in deliverables
- Client liaison and key CRO representative for Medical Writing activities in bid defence work
- Review of resource and budget estimations for Medical Writing section of proposals in line with the CRO business model
- Budget forecasting and stewardship for the Medical Writing department
- As a member of the CRO management team, drive the development and implementation of new technologies, standards, and programming methodologies within the CRO
- Conduct performance management and support personal development of employees
- Delivery of agreed Medical Writing activities to the client within budget, timelines, and resource targets
- Lead and support change by encouraging diversity of solutions that are value demonstrated
Qualifications
- Master’s degree in a life science, science-related or medical subject (or equivalent experience) or/and PhD in a life science, science-related or medical subject preferable
- Preferably 8 years’ experience preparing medical writing documents in the pharmaceutical industry, biotechnology, or medical sector
- Significant knowledge and experience on regulatory requirements and guidelines for scientific communications
- Demonstrated ability to manage others
- Published author of scientific literature desirable
Options
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed