Principal Medical Writer; Consultant, Regulatory Submissions

Principal Medical Writer (Consultant, Regulatory Submissions)

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For the past 20 years, Pro Pharma 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. Pro Pharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro Pharma 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 Pro Pharma clients.

Location:

Raleigh, NC

• 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…