The Sr. Medical Writer writes, edits, and compiles written deliverables within the Allucent Consulting Business Unit. Deliverables are focused in the disciplines of chemistry, manufacturing, and controls (CMC); nonclinical; clinical; medical affairs; and/ or regulatory affairs. Deliverables may be for submission to regulatory agencies, sponsor use, or for publication or presentation. This position leads and contributes to scientific discussions regarding the planning, production, and review of written deliverables. The Sr. Medical Writer is a member of the medical writing staff. The Senior Medical Writer will serve on project teams in various capacities including but not limited to: Medical Writer, Assistant Consulting Project Lead, Consulting Project Lead, and Program Director. The Senior Medical Writer may have one or more direct reports
Responsibilities of the role:
- Writes, edits, and compiles written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC); nonclinical; clinical; medical affairs; and/ or regulatory affairs for submission to regulatory agencies (e.g., U.S. Food and Drug Administration), sponsor use, or for publication or presentation
- Leads or contributes to scientific discussions regarding the planning, production, and review of written deliverables
- Performs literature searches and literature reviews, as assigned
- Has knowledge, commensurate to experience, of industry best practices and Health Authority Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
- Seeks professional development opportunities to maintain knowledge of regulatory requirements and industry best practices. May include relevant certifications (RAC, MWC, CMPP, CCRP)
- Displays knowledge, commensurate to experience, of company templates, requirements, and resources related to the production of written deliverables · Adheres to established company or sponsor practices or guidelines as directed by the project manager
- Leads or assists in the development of templates and guidelines for regulatory and other written deliverables · Performs other medical writing–related duties, both client-related and internal, as assigned ·
- Edits and guides the writing of clinical/scientific documents written by other team members or by clients
- Mentors less-experienced Medical Writers
- Applies company policies and procedures to resolve issues
- Identifies and mitigates risk
- Assures good communication and relationships with current and prospective clients
- Assists in the evaluation of potential technologies
- Contributes to Business Development activities, including input on proposals containing written deliverables, and participates in bid defense presentations when requested
- Actively manages, develops, and strengthens client relationships; drives repeat business
- Contributes to and participates in client evaluations
