Principal Medical Writer
Principal Medical Writer
Catalyst Clinical Research
Job description
Looking to build a career leading regulatory medical writing teams? Explore this Principal Medical Writer role at Catalyst Clinical Research, based remotely in India.
Company Description
Catalyst Clinical Research offers flexible, customizable solutions to the biopharmaceutical and biotechnology industries. Through Catalyst Oncology, a full service oncology CRO, and Catalyst Flex, multi therapeutic global functional and CRO services, the company supports clients worldwide. With a customer centric model, innovative technology, expert teams, and a global presence, Catalyst Clinical Research helps advance clinical studies across different therapy areas.
Job Summary
This remote role leads regulatory and medical writing deliverables for Catalyst's Flex Operations team. As a Principal Medical Writer you will review top-quality documents. These include study reports, protocols and briefing books. The documents are for agencies such as the FDA and EMEA. You will also design team training programs. Leading client accounts is part of your role. You will support audit readiness across the medical writing department.
Key Responsibilities
Author and review customer service representatives, protocols, information bulletins, briefing books and other regulatory submission documents.
Contribute to manuscripts, abstracts, posters and technology commercial documents.
Work with data analysts and statisticians, on real world evidence projects.
Write documents with scientific accuracy, following quality and editorial standards.
Follow internal and client processes, along with ICH and regulatory guidelines.
Carry out quality control, scientific reviews, and proofreading of writing deliverables.
Adapt writing style and timelines based on client and therapy area needs.
Lead client and KOL interactions, kickoff meetings, and calls across time zones.
Act as project or delivery lead for assigned client accounts.
Support innovation efforts, including automation and process improvement.
Design and run training programs for the medical writing team.
Guide the development of SOPs, work instructions, and related documentation.
Support business expansion and department operations as needed.
Oversee departmental staff, including hiring, training, coaching, and performance management.
Educational Qualification
PharmD, M.Pharm, PhD, MD, or a postgraduate degree in life science, medical, or paramedical studies.
Skills Required
10 to 11 years of experience in writing and in drug development and in clinical research.
5 years of experience in core medical writing and in focusing on regulatory deliverables.
Experience in writing and in writing publications and manuscripts is a plus.
Proficient in Microsoft Word, using macros and related features.
Excellent written, oral communication skills and presentation skills.
Strong organizational, analytical and problem solving skills.
Ability to handle shifting priorities and to manage projects at the same time.
Strong interpersonal skills and ability to work with people, at all levels of the organization.
Salary Structure
The average annual salary of Principal Medical Writer at Catalyst Clinical Research in India typically ranges between ₹20 Lakhs to ₹25 Lakhs per year.
Career Development
This role offers leadership exposure, by managing teams, training programs and key client accounts. Catalyst Clinical Research also supports long term growth through innovation driven projects and opportunities to build expertise in regulatory medical writing.
How to Apply
Visit our job portal and search for the Principal Medical Writer role in Catalyst Clinical Research.
Click on the listing to view the full job details.
Fill in your information and upload your resume.
Submit your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
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.