Principal Medical Writer - Regulatory Writing

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. 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., 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., 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. 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., Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., 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. 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. 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. 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 casebycase basis. We are committed to diversity, equity, and inclusion. We do not rely on AI screening tools to support our hiring process. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid