The Principal Medical Writer position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to ProPharma clients.

• Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable.
• Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents) as assigned.
• Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned.
• Independently authors (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, trains, and mentors less experienced medical writers, as necessary.
• Adheres to established regulatory standards/guidelines including but not limited to: ICH E3 or 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.
• Independently 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 medical 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.
• If requested by supervisor, 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 and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.).
• Other duties as assigned.

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 7 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.