The Regulatory Medical Writer-Clinical trials (RMW-CT) is responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. The RMW provides support for the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials such as documentation of previous interactions with HAs and sponsor, clinical development documentation, scientific literature, and content provided by sponsor team. The RMW may be the lead contact for sponsor or designated HAs interactions with cross functional teams contributing to the preparation of submission materials, including project and timeline management activities. The RMW is responsible for ensuring the accuracy and quality of submission-ready documents using established and effective sponsor and/or internal writing processes. The RMW partners with the sponsor/HAs leadership to prepare high-quality, accurate and concise documentation supporting the objectives of sponsor/HAs teams and leadership.
Job Requirements and Qualifications :
- RMW serves as the regulatory lead representative on project teams by partnering with the JSTL outsourcing and operational teams including functional area contributors (eg, Clinical, Data Management, etc.) to prepare a high-quality, clearly-messaged documents founded in regulation and supported by the science. These documents include but not limited to Clinical Study Reports (CSR), Clinical Summaries, Clinical Responses, and Protocol Summaries for submission to the sponsor and/or HAs.
- Must be highly competent to understand the Clinical Trial Protocol elements including study designs, data analysis, timelines and patient recruitment. Coordinate the review, approval, QC, and other appropriate functions involved in the production of regulatory projects.
- Arrange and conduct review meetings with the team.
- Independently resolve document content issues and questions arising during the writing process.
- Prepare scientific communications for external publication in peer-reviewed journals and presentations at scientific congresses. These documents include manuscripts, abstracts, posters and oral presentations
- RMW provides leadership and project management expertise for ongoing programs and/or projects and initiatives.
- Ensure accurate and timely completion/delivery of information and review of regulatory submissions to the sponsor or its designee.
- Communicate regularly with JSTL leadership on timeline/milestone progress for any assigned program.
- Assess resource needs as timelines progress and communicate any addition resource requests to department management team.
- Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH, CDSCO) and other governing bodies by following applicable divisional guidelines, templates, and standard operating procedures (SOPs).
- Proactively identify and implement tactical process improvements.
- Mentor and provide guidance and oversight to support staff including other participating writers and/or external vendor resources and agencies.
- A minimum of a Bachelor of Science in life sciences with significant relevant writing experience.
- A relevant advanced degree (e.g. MS 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.
- Good understanding of clinical development processes including principles of clinical study operations, ICH-GCP guidelines, and IJME guidelines.
- High-level content writing experience and experience with clinical development regulatory documents required, with working knowledge of statistical concepts and techniques.
- Excellent written and oral communication skills.
- Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
- Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Peer-review and editing skills are a plus.
- Knowledge and expertise with Common Technical Document (CTD) content templates, electronic document management systems and information technology.
- Excellent working knowledge of software programs in Windows environment including MS Word/ PowerPoint/ Excel, and Adobe Illustrator