The Associate Technical Writer, is responsible for preparing CMC elements of regulatory filings under a Technical Writer’s guidance and supporting the regulatory activities for pre and post submissions for biologic products.
This role requires effective collaboration across technical functions to deliver on timelines for submissions. The candidate must have a working knowledge of regulatory submissions for pre and post filings. The position routinely interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Science and Technology, Quality and Regulatory Sciences. The successful candidate will work effectively in cross functional project teams and also independently to accomplish company goals.
Prepare under supervision CMC elements of regulatory filings.
Support integrated review process for authored sections. Support the operation of the review process and creates updated draft for next phase review.
Participate in initiatives (creation of templates) involved with regulatory filings.
Support the logistical process for regulatory submissions including pre and post submissions while interfacing across the BMS network as needed.
Assist in the facilitation of authoring, review, verification and submission-ready compliance for the finalization of filings as needed.
Participate on various cross-functional project teams, interactions with Technical Operations and GRS-CMC staff at different BMS sites and other key partners both internal and external to the company are necessary.
Must possess the ability to support multiple projects.
Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
Works under supervision and collaborates with other groups.
BS with 2-5 years of pharmaceutical experience or MS degree. Advanced degree is an asset.
Excellent organizational and communication skills are required along with proficient navigation of electronic systems.
Proven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication.
Must have a working knowledge of regulatory submissions for pre and post filings.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions.