Principal Medical Writer (Cardio/Metabolic Health)

TL;DR

Principal Medical Writer (Cardio/Metabolic Health): Authoring and editing high-quality clinical, safety, regulatory, and device/diagnostics medical writing deliverables across all phases of clinical research with an accent on FDA and other regulatory submission documents, QC coordination, and cross-functional client-facing delivery management. Focus on leading cross-functional coordination, supervising and mentoring medical writers, and ensuring on-time, within-budget deliverables aligned to ICH and EU MDR/IVDR standards.

Location: United States

Company

hirify.global provides regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology services for biotech, med device, and pharmaceutical organizations.

What you will do

• Manage clinical program documents for assigned clients, including protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, and complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents).
• Independently author and edit medical writing deliverables across clinical research phases and therapeutic areas, including plain language summaries and device/diagnostics-related documents.
• Lead cross-functional coordination of resources to manage medical writing and QC deliverables, including QC reviews and maintaining audit trails of changes.
• Independently manage client expectations, communicate directly with clients, lead meetings (kickoff, comment review), and manage deliverable timelines.
• Review statistical analysis plans and table/figure/listing shells for content, grammar, format, and consistency; perform peer review of other medical writers’ documents as required.
• Supervise, train, and mentor less experienced medical writers; support project administration (timelines, deliverable trackers, meeting hosting) and process improvement initiatives.

Requirements

• Minimum 7 years of experience writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a CRO, pharmaceutical company, or biotechnology company.
• Advanced knowledge of clinical research principles and ability to interpret and present clinical data and complex information.
• Advanced understanding of FDA (and other relevant regulatory bodies) regulations and regulatory submission requirements and processes.
• Expert word processing skills in MS Word, including tables, graphs, and figures.
• English proficiency and familiarity with American Medical Association (AMA) style.
• Strong project management and communication skills with high attention to detail and quality.

Culture & Benefits

• Hybrid work encouraged for new hires within a reasonably short commute of an office, with time spent working from the office as agreed with the manager.
• Commitment to diversity, equity, and inclusion and an equal opportunity workplace.
• Applications are personally reviewed by the recruitment team, with an outcome provided for each application.