Principal Medical Writer (WFH role)
Principal Medical Writer (WFH role)
Syneos Health
Job description
Want to handle global regulatory medical writing projects? Explore this remote job vacancy of Principal Medical Writer at Syneos Health.
Company Description
Syneos Health is an integrated biopharmaceutical solutions organisation supporting customers across clinical development, medical affairs, and commercial services. It combines clinical, scientific, and operational expertise to help customers address drug-development challenges. Through functional service provider and full-service partnerships, its teams collaborate to accelerate therapy development and delivery for patients worldwide.
Job Summary
The role as a Principal Medical Writer, involves creating global regulatory submission materials and providing strategic guidance to cross-functional teams with minimal supervision. The role also includes creating clinical materials such as Investigator Brochures, Clinical Study Reports and marketing-authorisation filings.
Key Responsibilities
Prepare clinical and regulatory documentation for submission to regulatory bodies globally in accordance with ICH guidelines, global regulatory standards, established processes and appropriate client authoring needs.
Lead medical writing projects and timelines in partnership with research teams and project teams.
Liaise with cross-functional members to guarantee timely delivery of documents and efficient review cycles.
Review linked clinical documentation (e.g. research protocols, Statistical Analysis Plans (SAPs)).
Engage in cross-functional process improvement efforts and assist in development of Standard Operating Procedures (SOPs) and best practices for efficient production of high quality regulatory papers.
Lead and mentor internal and contract medical writing resources to achieve project deadlines.
Mentor junior medical writers, guiding them to support document quality and professional development.
Educational Qualification
A Bachelor's degree in Life Sciences, or another relevant scientific discipline from a recognised university.
Skills Required
Ability to write high-quality clinical and regulatory documents for submission to worldwide regulatory bodies.
Knowledge of ICH recommendations, global regulatory standards, writing requirements, and clinical documentation processes.
Demonstrated ability to manage several medical writing projects, and ensure timely completion of deliverables.
Ability to present clinical facts accurately, consistently and rationally in regulatory documentation.
Can lead and organise internal and contract medical writers, assist in process improvements and mentor junior staff.
Salary Structure
The average salary of a Principal Medical Writer at Syneos is ₹7 Lakhs-₹8 Lakhs per year.
Career Development
This role as a Clinical Writer can develop skills in global regulatory submissions, clinical document strategy, ICH guidelines, cross-functional project leadership and quality systems. Experience in directing complicated submissions and training writers may lead to Associate Director, Director of Medical Writing or more general regulatory writing leadership roles.
How to Apply
Open our job portal. Search for Principal Medical Writer (WFH role) listing.
Review the full job information and check the eligibility conditions.
Fill out the application form.
Upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Need a resume for this job?
Start from our Medical Writer resume template, with example points and skills ready to click in. ATS-friendly, and downloads as a PDF.
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.