Senior Medical Writer, Cardio/Metabolic Health

Essential Functions

• writes/edits high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents)
• 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 (e.g., project kickoff, comment review), and manages the deliverable timelines
• interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables
• coordinates QC reviews of documents 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 QC review (e.g., reviews in-text tables against statistical output)
• 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
• brings 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
• ability 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

Educational 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