Job Description

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.

Key Responsibilities

Regulatory Consulting, Medical Writing

• 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 \xe2\x80\xa2 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\xe2\x80\x93related 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

Management, Learning & Development

• Actively supports staff learning & development
• Provides guidance and advises Project Leads and/or Project Teams
• Adheres to project budgets and contracts including scope and scope changes, timelines, and active resource management
• Manages projects as a Technical Lead, as assigned
• Leads and/or participates in meetings with clients
• Provides mentorship to team members
• Acts professionally with peers and clients and practices good business etiquette

Quality Management

• Applies company policies and procedures to resolve issues.
• Identifies and mitigates.

Business Development

• 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

Others

• Contributes to other areas of business as required
• Office environment with ability to lift up to 25 pounds, if required
• Travel may be required

Requirements

Qualification

• Candidates with a B.S., or equivalent degree, in a scientific area, with M.S., Ph.D., Pharm.D., M.D., or equivalent degree, in a scientific area strongly preferred
• Regulatory knowledge of drug, biologic, or device development focusing on submission requirements for US, EU, and/ or Canada.

Skills

• Critical thinking and analytical skills, as well as strong written and verbal communication skills in English \xe2\x80\xa2 Scientific and regulatory knowledge of drug, biologic, or device development is desirable.
• Quality focus and attention to detail
• Emotional intelligence, customer-focused leadership, and good decision-making skills
• Innovative, creative, and practical thinking, including the ability to problem-solve effectively
• Proficient in relevant software including Microsoft Office (Word, PowerPoint, Excel), Adobe Acrobat (or other PDF software), and web-based meeting platforms
• \xe2\x89\xa54 years of experience with regulatory requirements of US FDA, Health Canada and / or European authorities, including medical writing experience.

Allucent