Job: Senior Specialist CMC Technical Writer– Regulatory Affairs, Medicago USA, Durham, NC
Senior Specialist CMC Technical Writer– Regulatory Affairs
Durham, NC 27709 United States
Documentation & Technical Writing
Manufacturing and Production
Reporting to Vice President or Director, Regulatory Affairs at Medicago, the occupant of this position is 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. Strong links need to be established with all involved Medicago departments and external partners, as applicable, to ensure dossiers are compiled, submitted and approved in an efficient and timely manner.
Principal functions and responsibilities:
• Leads development, authoring and critically analyzes and interprets CMC related technical data to write program-level eCTD compliant documents such as module 3 sections, module 2 summaries (QOS), briefing documents and other documents needed to support regulatory interactions and filings. (Familiarity with Veeva Vault an asset)
• Provides strategic guidance on development of CMC related studies in collaboration with other applicable functional areas (Quality Control, Analytical Development, Process Development, etc.).
• Contributes to assessments (including change controls) and mitigation plans of CMC related risks.
• May lead development and authoring of publications, including manuscripts for peer-reviewed journals, and abstracts, oral presentations, and posters presentations for medical/scientific congresses and medical society meetings in collaboration with internal CMC technical teams and external researchers and/or scientists.
• Reviews and provides assistance on answering deficiency letters from regulatory agencies, as required.
• Performs literature searches/reviews as necessary to obtain background information for development of documents.
• Manages the review and approval of documents, including leading cross-functional team-level and management-level document reviews and comment adjudication meetings.
• Performs quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
• Develops, manages and communicates document-specific timelines to team members to maintain awareness of expectations and milestones and ensure on-time deliverables that support corporate goals.
• Advises teams on format requirements for documents and may advise on content.
• Participates in the development of technical writing departmental infrastructure, including standard operating procedures, work instructions/guidelines, templates, style and content guides, and document quality control to ensure consistent preparation of high-quality technical writing deliverables.
• Assists in the interviewing, mentoring, and integration of internal technical writing staff as needed.
• Maintains CMC subject area expertise related to the company’s investigational products and ensures adherence to appropriate regulations and guidelines.
• Provides timely and appropriate reports to the Vice President, Regulatory Affairs.
Qualifications and Experience
• A solid understanding of the drug development process, including documents that are required at each stage and the regulatory environment, such as HC/FDA/EMA/ICH.
• A minimum of 7 years of technical writing experience in the biopharmaceutical industry plus a university degree in a life-science-related discipline, health-related field, communications, or technical writing is required OR an advanced scientific degree (PhD, PharmD, or MS) plus 5 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.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• 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.
• Excellent 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, tables, spreadsheets, presentations, graphics, slides and templates, in addition to Adobe Acrobat.
• Bilingualism (English-French) an asset
Do you know someone who would be interested in this job?