Senior Medical Writer

Essential Functions

• Authors high-quality medical writing deliverables (e.g., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas.
• Supervises and mentors less experienced medical writers, as necessary.
• Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
• Strives to complete medical writing deliverables on time and within budget.
• Manages client expectations and interacts and communicates directly with clients, leads team meetings, and manages the deliverable timelines.
• Collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
• Captures and maintains audit trails of changes as applicable.
• Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.
• Performs peer review of documents written by other medical writers, as required.
• Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
• Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
• Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
• Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
• Bridges issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team.
• Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.).

Necessary Skills And Abilities

• Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.
• Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.
• Advanced understanding of regulatory submission requirements and processes.
• Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.
• Exceptional project management skills and strong communication skills with a high attention to detail and quality.
• English language proficiency and familiarity with American Medical Association (AMA) style.
• Strong experience in relationship building and strategic collaboration on key business accounts.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• Able to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.
• Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.
• Works effectively in a collaborative team environment.
• Demonstrates a growth mindset and positive outlook in all work activities.

Education Requirements

Bachelor’s degree or higher, preferably in medical or scientific discipline.

Experience Requirements

Minimum of 5 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.

Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.