| Job Description |
- 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.
- 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.
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| Requirements |
- 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 CMC 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 CMC 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
If you have the skills and experience that we are looking for to be successful in this role please submit your resume by email to ronhaby@winterstaffing.com Phone 905-542-9611
www.winterstaffing.com
We are an equal opportunity Employer
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