Regulatory Submission Writer
Site Name: USA - Pennsylvania - King of Prussia Posted Date: May 12 2021 Are you energized by the opportunity to focus on technical writing and project management? If so, then this regulatory submission writing role could be an ideal opportunity to explore. This is a relatively new role within GSK's CMC Biopharmaceutical organization that straddles the technical and regulatory departments reporting into a Dossier Strategy Group. The role is for anyone with the desire to focus on technical writing, project management, and learn about biopharmaceutical development through commercialization. Personal development and visibility are at the heart of this role, and there is a great opportunity to learn and develop from SMEs from all facets of CMC development, manufacturing, testing, and regulatory affairs. Why you? Basic Qualifications: Bachelor's degree in science or engineering with a minimum of 5 years of industry experience in development, quality, manufacturing, or regulatory fields in the biopharmaceutical/biotechnology industry. At least 3 years of experience in scientific writing and editing of technical documents including global regulatory submissions, process development reports, and/or validation documents. Preferred Qualifications: The successful candidate needs to demonstrate the following behaviours: Excellent ability to communicate in writing and influence others. Willingness to learn about areas outside own technical experience. Ability to work independently and deliver to shifting deadlines. Detail oriented, with ability to apply a clear, concise, and consistent writing approach across different technical content. Ability to build strong relationships across technical functions in order to effectively negotiate with other groups and resolve problems. Capability to organize, prioritize, and adapt to changing timelines. Has a continuous improvement mindset with respect to the writing process, and an ability to enable and drive change. Ability to use flexible thinking and creativity to find practical solutions to uncharted problems. Ability to function in a new organizational shifting environment. Detailed Responsibilities: In order to deliver high quality CMC Regulatory submissions, this role will support the organization to: Coordinate the authoring, assembly, and review of CMC sections in the common technical document (CTD) format for global regulatory submissions to ensure conformance with department standards and regulatory guidelines. Review technical reports and adapt them to Regulatory content in line with GSK regulatory document templates. Compile, review, and edit CMC regulatory documents to ensure high quality scientific content, clear organization, and proper formatting. Collaborate with both technical and regulatory subject matter experts regarding the preparation, editing, and review of technical reports to support regulatory submissions. Interact directly with the Biopharmaceutical CMC Regulatory Affairs group and subject matter experts from development, manufacturing, and quality groups to obtain source documentation and facilitate the development, review, approval, and submission of CMC regulatory documents. Provide guidance and feedback to authors, co-authors, and reviewers on content and the writing process based on updated regulatory templates and advice from the Biopharm CMC Regulatory Affairs group. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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