Senior Medical Writer
On-siteBengaluru, Karnataka, India
Job Summary
Senior Medical Writer at Excelya within Medical Affairs, responsible for producing regulatory and medical writing deliverables (e.g., protocol, summary, informed consent forms, investigator brochures) and coordinating cross-functional teams (Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure compliant, high-quality publications. Responsibilities include writing/editing complex medical writing deliverables (clinical study reports, CTD submissions, IBs), ensuring accuracy and regulatory compliance, contributing to document quality control, mentoring other writers, liaising with sponsors to align on deliverables, adhering to SOPs and applicable legislation, performing literature reviews, reviewing statistical analysis plans, staying current with guidelines, and supporting other teams as needed. Must have English proficiency, knowledge of ICH; CONSORT, STROBE, PRISMA guidelines; and a life-sciences degree; ideally Master’s or related postgraduate study.
Required Qualifications
- About You
- At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
- Experience: Senior Medical Writer, a relative experience of up to 3 years in medical writing is considered a plus.
- -Analytical skills and ability to interpret data
- -Attention to detail
- -A strong work ethic
- -Intellectual curiosity and creativity
- -The ability to work effectively in a team in a fast-paced and dynamic environment
- -Advanced level of English
- -Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines
- -Interpersonal and leadership skills
- Education: University graduate in life sciences or equivalent (post-graduate studies in a related field are considered a plus)
- Languages: Fluency in English (mandatory)
- Benefits
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.