CMC Sr. Technical Writer

We are seeking for 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. Timely and efficient submission and approval of documents will be key to success for this role as CMC Technical Writer - Content, Strategy, and Development.

Primary Responsibilities:

• Leads development, authoring, analyzing, and interpretation of CMC related technical data (from SOPs, Batch Records, Reports, etc.) to author INDs and IMPD sections, module 2 summaries (QOS), briefing documents, and other documents needed to support regulatory interactions and filings for CMC.
• Performs quality control (QC) 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.
• Manages the review and approval of documents needed for regulatory filings.
• Manages and communicates document-specific timelines to team members to ensure on-time deliverables are completed.

Education/Experience and Skills Requirements:

• A solid understanding of the drug development process, including documents that are required at each stage and the regulatory environment, such as FDA/EMA/ICH.
• A minimum of 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 an 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 lead
• Ability to develop and execute strategies
• Handle issues appropriately and with a sense of urgency
• Strong leadership to support a multi-project environment in small biotech or large pharma