Proactively identify and implement tactical process improvements.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.Assess resource needs as timelines progress and communicate any addition resource requests to department management. Communicate regularly with RSW leadership on timeline/milestone progress for any assigned program.Independently resolve document content issues and questions arising during the writing process. Arrange and conduct review meetings with the team. Coordinate the review, approval, QC, and other appropriate functions involved in the production of regulatory projects.Ensure all RA electronic doc deliverables are processed and compiled in alignment with timelines. Convert relevant data into a form that meets RA doc requirements. Confirm quality and completeness of info to be presented. Explain and prepare data in manner consistent with RA requirements. Ensure required documentation is obtained. Understand, assimilate, and productively interpret info sources with appropriate guidance/direction from GRPT and/or authors/KOLs.In pursuit of this responsibility the Principal Writer is to work closely with GRPT members on the strategic content of target documents. Determine and communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Provide leadership and project management expertise for compound programs and/or RSW projects and initiatives.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.The PW partners with the GRL/Area Lead to prepare high-quality, accurate and concise documentation supporting the objectives of GRPT teams and leadership. The PW is responsible for ensuring the accuracy and quality of submission-ready documents using established and effective RSW writing processes. The PW 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 PW provides support for the preparation and submission of critical RA documents and responses to health authority information requests using available reference materials such as documentation of previous interactions with HAs, clinical development documentation, scientific literature, and content provided by GRPT team members. The Principal Writer (PW) is responsible for providing RA strategic document expertise and support to one or more TAs as designated by RSW leadership.
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