Principal Medical Writer

ProPharma; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

ProPharma, une entreprise renommée en consultant médical, recherche un Principal Medical Writer pour rejoindre son équipe à Raleigh, Caroline du Nord. Le candidat idéal aura plus de 7 ans d'expérience dans l'écriture de documents cliniques et réglementaires, ainsi qu'une forte compétence en gestion de projet et communication. Ce rôle implique la supervision des livrables de rédaction médicale, la collaboration avec des experts de la matière, et l'adhérence aux normes réglementaires établies.

Qualifications

• Licence médicale ou scientifique requise.
• Minimum de 7 ans d'expérience dans l'écriture de documents cliniques ou réglementaires.
• Anglais courant et familiarité avec le style AMA.

Responsibilities

• Gérer la documentation clinique pour les clients, y compris les protocoles et rapports.
• Former et superviser les rédacteurs médicaux moins expérimentés.
• Respecter les normes réglementaires et gérer les attentes des clients.

Skills

Project Management

Communication

Attention to Detail

Problem Solving

Education

Bachelor’s degree or higher in a medical or scientific discipline

Tools

MS Word

Job description

Join to apply for the Principal Medical Writer role at ProPharma.

For the past 20 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. ProPharma 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, 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.

Essential Functions

• Ensure appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants.
• Manage clinical program documents for assigned clients, such as protocols, amendments, IBs, ICFs, study reports, and regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents).
• Lead cross-functional coordination of resources to manage medical writing and QC deliverables.
• Author and edit high-quality medical writing deliverables across all phases of clinical research and therapeutic areas, including protocols, reports, narratives, IBs, ICFs, and complex regulatory documents.
• Supervise, train, and mentor less experienced medical writers.
• Adhere to regulatory standards and guidelines, including ICH E3/E6(R2), EU MDR/IVDR, and client standards.
• Strive to complete deliverables on time and within budget.
• Manage client expectations, communicate directly with clients, lead team meetings, and manage timelines.
• Collaborate with subject matter experts to produce medical writing deliverables.
• Coordinate QC reviews, maintain audit trails, and review statistical plans and outputs.
• Perform peer reviews and support administrative tasks related to projects.
• Stay updated on industry practices, regulations, and guidelines.
• Understand budget constraints, manage workload, and escalate issues as needed.
• Participate in departmental initiatives and other duties as assigned.

Necessary Skills And Abilities

• Advanced knowledge of clinical research principles and data interpretation.
• Understanding of FDA and other regulatory bodies and guidelines.
• Proficiency in MS Word and experience with tables, graphs, and figures.
• Strong project management and communication skills with high attention to detail.
• English proficiency and familiarity with AMA style.
• Experience in relationship building and strategic collaboration.
• Proactive thinking, initiative, and problem-solving skills.
• Ability to work independently and in a team, with effective time management.
• Growth mindset and positive attitude.

Educational Requirements

• Bachelor’s degree or higher in a medical or scientific discipline.

Experience Requirements

• Minimum of 7 years in writing clinical/regulatory documents for drugs, biologics, or medical devices.

We celebrate diversity and are committed to creating an inclusive workplace. ProPharma Group does not accept unsolicited resumes from recruiters or third parties. No phone calls or emails regarding this posting.