AMS PRACTICE MANAGEMENTS is currently looking to fill a contact base position of Chemistry Manufacturing and Controls (CMC) Technical Writing Expert.
Excellent written skills in English
Exhibits clear style (readable, concise, cohesive, appropriate terminology)
demonstrates accurate language usage (grammar, punctuation, spelling)
Demonstrable Analytical Thinking, Logical Deduction, Statement & Conclusion
Demonstrates accurate, thorough, relevant, and coherent content and ideas
Experience in converting complex technical concepts into text, tales and figures
Strong working knowledge of Microsoft Office
Uses parallel structure with heading and subheadings
Passion for regulatory CMC strategy
Knowledge of ICH CTD and required content
And the ability to
complete writing assignment according to set timelines and standards
edit, standardize, or make changes to documents prepared by other writers without completely re-writing them
communicate complex and technical information effectively
develop, gather, and disseminate or facilitate the transfer of technical information through an organization's communications channel or between two or more parties
work with product teams to understand the product , process or change
engineer solutions to provide or create Health Authority-facing documentation for various products.
manage several projects in the same timeframe
track (organize, manage and maintain) a large set of technical source documentation and their relationship to the authored regulatory documents
maintain records and files of work and revisions.
participate in the standardization process for creating technical documentation across products.
The Chemistry Manufacturing and Controls (CMC) Technical Writing function resides organizationally within Regulatory Affairs and is responsible for the strategic planning and management of CMC submission projects in alignment with business goals, to facilitate achievement of corporate objectives.
Develop and lead the execution of regulatory CMC submission plans.
Contribute strategically and scientifically at the project and/or team level. Contribute to the definition of the CMC content requirements. Proactively identify issues and solutions to keep to timelines.
Plan and manage document authoring resource needs for submission projects, and coordinate the authoring, review and approval of submission-ready documents.
Interpret and summarize complex data. Serve as the primary author and lead writer for of CMC documents intended for submissions to Global Health Authorities using assigned templates and style guide, with minimal supervision.
Ensure key messages are clear and consistent within and across documents. Ensure the vocabulary is consistent throughout the submission.
Develop and foster constructive working relationships with internal and external colleagues
B.S. in a scientific or technical discipline with 8+ years of experience in pharma or related experience.
Experience with small molecules and biologic new molecular entities preferred.
Extensive experience in the organization and format of ICH CTD M3 required.
Demonstrated ability for concise and precise technical writing for submissions, aligned with the principles of ICH Q12 and Established Conditions guidance.
Experience writing QOS and Health Authority Query responses preferred.
Knowledge of drug development lifecycle, and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required
Excellent project management skills. Ability to adapt to a dynamic product development environment and track diverse project deliverables.
Strong expertise with Microsoft Word. Proficient with Microsoft Excel, Project and PowerPoint