Senior Regulatory Medical Writer, Clinical trials
Senior Regulatory Medical Writer, Clinical trials
Jeevan Scientific Technology Limited
Job description
Jeevan Scientific Technology Limited has open positions for the role of Scientific Regulatory Medical Writer: Clinical trials role at Hyderabad. This is a great opportunity for MSc Pharmacy, PharmD, PhD and MD graduates.
Company Description
Jeevan Scientific Technology Limited, is a Global Management Consulting, Technology Services and Outsourcing Healthcare Services company based out of Hyderabad. Established in 1999, Jeevan Scientific Technology Limited is a BSE listed company. With state-of-the-art facilities, Jeevan Scientific Technology Limited provides a wide range of clinical research services to various healthcare/pharmaceutical industries globally.
Job Summary
The Senior Regulatory Medical Writer: Clinical trials (RMW-CT) will provide strategic document support and regulatory affairs (RA) expertise to one or more therapeutic areas (TAs) as defined by leadership. The RMW will support the preparation of key RA documents and responses to information requests from the health authority (HA) and Sponsor using reference material such as historical HA/sponsor interaction documents, clinical development documents, scientific literature and sponsor team content.
Key Responsibilities
As a regulatory medical writer, you will be responsible for:
Arrange and conduct review meetings with the team.
Resolving content issues independently.
Writing scientific documents, including manuscripts, abstracts, posters and oral presentations for publication and presentation at scientific congresses.
Providing leadership and project management for ongoing programmes and/or projects/ initiatives.
Ensuring accurate and timely delivery of information for review of regulatory submissions to Sponsor or their representative.
Provide regular update to JSTL leadership on progress against deadlines and milestones for any assigned programme.
Identify resource requirements and raise requests for additional resources.
Understanding of appropriate standards, correct grammar and formatting for regulatory documents (ICH, CDSCO) etc. This will be achieved by following the relevant guidelines, templates and SOPs within the division.
Being proactive in identifying and implementing improvements.
Mentoring and providing guidance to support staff including any other writers and/or vendors.
Educational Qualification
To become a regulatory medical writer you will require:
A minimum of a Bachelor of Science in life sciences with significant relevant writing experience.
A relevant advanced degree (e.g. MSc Pharmacy, PharmD, PhD, MD) is preferred, and higher education may compensate for years of experience.
A certificate in regulatory affairs and/or medical writing is highly preferred.
Minimum of 2-4 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, clinical research (Phase I-IV), or product support/R&D.
Skills required
Skills required for a regulatory medical writer role are:
Good knowledge of clinical development processes, clinical study operations, ICH-GCP and IJME guidelines.
Strong writing skills with experience of writing regulatory documents within clinical development. Knowledge of statistical principles.
Excellent communication skills.
Skilled in assimilating scientific information and translating it for the correct audience.
Very detailed with the ability to identify and correct spelling, punctuation, grammar, consistency, clarity and accuracy issues.
Peer review and editing skills are advantageous.
Knowledge of CTD templates, EDP systems and IT.
Excellent knowledge of software packages including MS Word/PowerPoint/Excel within a windows environment and Adobe Illustrator
Salary Structure
The average salary of a Regulatory Medical Writer at Jeevan Scientific Technology ranges from ₹5.8 Lakhs to ₹6.4 Lakhs per year.
Career Development
As a Senior Regulatory Medical Writer, this role would provide you with a career path from technical delivery to global strategic leadership within clinical development. Jeevan Scientific technology limited will provide you with a clear career path allowing you to increase your influence beyond document writing.
How to Apply
Go to our jobs page and search for Senior regulatory medical writer role at Jeevan Scientific Technology limited.
Click on the role to see further details.
Complete your details and upload your CV.
Submit your application.
Education
Bachelor's Degree
Key Skills
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Market insights & trends
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