The Principal Writer is responsible for providing regulatory strategic document expertise and support to one or more Therapeutic Areas (TA) as designated by RSW leadership. The Principal Writer provides support for the preparation and submission of critical regulatory documents (e.g. briefing books) and responses to health authority information requests using available reference materials such as documentation of previous interactions with healthcare authorities, clinical development documentation, scientific literature, and content provided by Global Regulatory Product Team (GRPT) team members. The Principal Writer may be the lead contact for RSW interactions with cross functional teams contributing to the preparation of submission materials, including project and timeline management activities. The Principal Writer is responsible for ensuring the accuracy and quality of submission-ready documents using established and effective RSW writing processes. The Principal Writer partners with the Global Regulatory Lead/Area Regulatory Lead to prepare high-quality, accurate and concise documentation supporting the objectives of GRPT teams and leadership.
- Serve as the RSW lead representative on project teams by partnering with the GRPT including functional area contributors (eg, Clinical, Pharmacovigilance, CPPM, etc.) to prepare a high-quality, clearly-messaged documents founded in regulation and supported by the science.
- Provide leadership and project management expertise for compound programs and/or RSW projects and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Determine and communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Principal Writer is to work closely with GRPT members on the strategic content of target documents.
- Understand, assimilate, and productively interpret sources of information (eg, scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRPT team and/or authors/key opinion leaders. Ensure required documentation is obtained. Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Challenge conclusions when necessary. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
- 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.
- Communicate regularly with RSW leadership on timeline/milestone progress for any assigned program. Assess resource needs as timelines progress and communicate any addition resource requests to department management.
- Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and 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 Bachelor’s degree is required, either a Bachelor of Science with significant relevant writing experience, or Bachelor degree in English or communications with significant relevant science experience. A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred, and higher education may compensate for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
- Minimum of 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, or product support/R&D.
- Minimum of 2 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
- 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.
- Advanced knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
- Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology.
- Excellent working knowledge of software programs in Windows environment.
- RA management
- Global Regulatory Product Team members and their associated Regulatory Leads
- R&D functional management and members involved in generating regulatory submission documents
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 5 % of the Time
Job Type: Experienced