Work Location: Bangalore
Responsible for preparation and coordination of complex clinical study protocols and clinical study reports (CSRs), and other documents as needed. Responsible for preparation of submission level documents. Provide review and feedback on documents prepared by the department. Performs the scientific review of clinical study outlines, protocols, statistical analysis plans, tables, figures and listings, and CSRs, ensuring high scientific integrity and correct data interpretation where applicable for all of these products. Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate. Production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc.). Provides technical leadership with responsibility for delivering Medical Writing Services to clients and internal Covance project teams. Ensure timely delivery of high quality documents to internal customers and Sponsors. Scientific presentations both internally within Covance and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Works with the management team to provide project leadership, guidance, mentoring and training to Medical Writers to ensure best working practices are maintained. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.
Essential Job Duties:
- These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
- Write and coordinate the development of protocols, CSRs or other clinical documents of any complexity
- Takes the lead in preparing submission level documents
- Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects
- Produces scientific papers, abstracts and/or posters, and presentations.
- Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines and budget requirements
- Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
- Act as medical writing lead and liaison for major clients and partners
- Represent company at scientific and medical writing forums
- Keep up to date with developments in Medical Writing
- Demonstrate detailed knowledge of Medical Writing industry requirements such as ICH and regulatory agency guidelines
- To regularly demonstrate initiative and ability to deal with medical writing situations independently. Present solutions and convince management and teams to adopt recommended strategies
- Lead Medical Writing initiatives to develop and improve processes, including new technologies. Persuade other department staff to accept and embrace new working practices
- Mentor staff and provide guidance and training to department
- Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences
- Write and review Covance SOPs and associated documents
- Represent department in audits and inter-department working groups
- Comply with Covance internal processes and procedures
- Performs other duties as assigned by Management