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CMC Senior Technical Writer

Title: CMC Senior Technical WriterJob ID: BM4209341018Location: New York, NYWe are seeking a motivated candidate who will be responsible for ensuring the coordination and management of Chemistry, Manufacturing, and Controls (CMC) regulatory documents related to all pre- and post-marketing activities in all regulatory jurisdictions. The ideal candidate is a hands-on team player that enjoys working in extremely collaborative working environment with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.Responsibilities:Leads development, authoring, analyzing, and interpretation of CMC related technical data, briefing documents, and other documents needed to support regulatory interactions and filings for CMC.Performs quality control and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.Reviews and aids in responding to requests for information from regulatory agencies, as required.Assists in the development of standard operating procedures, work instructions/guidelines, templates, style and content guides, and document quality control for technical writing to ensure consistent preparation of high-quality technical documents.Performs literature searches/reviews as necessary to obtain background information for development of documents.Perform other duties as assigned.Qualifications:Solid understanding of the drug development process, including documents that are required at each stage and the regulatory environment, such as FDA/EMA/ICH.3+ years of technical writing experience in the biopharmaceutical industry plus a university degree in a life-science-related discipline, health-related field, is required OR advanced scientific degree (PhD, PharmD, or MS) plus 2 years of technical writing experience in the biopharmaceutical industry.Excellent writing skills coupled with ability to edit complex material to ensure accuracy, clarity, and effectiveness.Demonstrated experience working with document contributors, including analytical experts, biostatistics, manufacturing operations and regulatory affairs to ensure appropriate collaboration and input into document development.Previous experience with and expert knowledge of cGMP guidelines is essential.Excellent attention to detail, communication, time management, organizational skills and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment.Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.Self-starter and must function well under minimal supervision.Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides and templates, in addition to Adobe Acrobat.Preferred Qualifications:Ability to effectively leadAbility to develop and execute strategiesHandle issues appropriately and with a sense of urgencyStrong leadership to support a multi-project environment in small biotech or large pharmaFor more information about TEEMA and to consider other career opportunities, please visit our website at

Job Category:  [ View All Jobs ]
Experience (years): Unspecified
Job Location: New York, NY USA
Job Location Zip/Postal Code 10001
Posting Company Type Employer
Post Date: 01/13/2021 / Viewed 0 times
Contact Information
Company: TEEMA

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