Principal Medical Writer

Nanosep AB; Reading; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading company seeks a Lead Medical Writer to manage writing projects, oversee customer accounts, and ensure high-quality deliverables. The role involves leading document preparation, managing timelines, and mentoring others. Ideal candidates will have extensive experience in medical writing and a strong educational background in life sciences.

Qualifications

• At least 8 years of relevant experience required.
• Deep knowledge of clinical study reports and protocols.

Responsibilities

• Lead preparation of assigned documents, confirming scope and negotiating timelines.
• Manage large Medical Writing projects across regions and functions.
• Design training materials and deliver knowledge-sharing sessions.

Skills

Communication

Negotiation

Attention to Detail

Education

Bachelor's Degree in life sciences

Master's Degree

Ph.D. in life sciences

Tools

Computer tools

Job description

Job Overview

Acts as Lead Medical Writer on various writing projects, advising others on document types. Capable of managing customer accounts, presenting, discussing, and answering questions about Medical Writing capabilities globally. Performs senior review of all medical writing deliverables, providing feedback, guidance, and identifying training needs. Communicates medical writing topics to broad audiences and manages timelines and customer feedback.

Keeps updated on current medical and technical writing, regulatory knowledge, GCP, and advances in drug development and medical writing.

Essential Functions

1. Lead preparation of assigned documents, confirming scope, templates, specifications, negotiating timelines, organizing reviews, and communicating with customers.
2. Plan and organize workload, identify project needs, track timelines, and implement customer requests.
3. Address new or unusual document types and customer requirements using experience and initiative.
4. Chair meetings and resolve conflicts using negotiation skills.
5. Participate in bid defense meetings and discussions.
6. Design training materials, contribute to training plans, and deliver knowledge-sharing sessions or workshops.
7. Manage large Medical Writing projects, coordinating activities across regions and functions, focusing on efficiency, consistency, budget, and customer liaison.
8. Monitor and forecast project budgets and hours, proposing and approving budgets within remit.
9. Lead or participate in global Medical Writing initiatives and represent Medical Writing in cross-functional SOP reviews, suggesting process improvements.

Qualifications

• Bachelor's Degree in life sciences or related field (Req)
• Master's Degree (Pref)
• Ph.D. in life sciences or related field (Pref)
• At least 8 years of relevant experience (Req)
• Deep knowledge of clinical study reports, protocols, and document deficiencies.
• Understanding of statistical methods and interpretation in clinical trials.
• Ability to review statistical analysis plans and outputs for accuracy.
• Experience in preparing CSRs, protocols, CTDs, and handling complex documents.
• Knowledge of drug development, medical writing regulations, and medical terminology.
• Excellent communication, attention to detail, negotiation, and interpersonal skills.
• Ability to manage multiple projects, demonstrate leadership, influence others, and build relationships.
• Proficiency with computer tools.

IQVIA is a global leader in clinical research and healthcare intelligence, committed to innovation and impact. Learn more at https://jobs.iqvia.com. We value diversity and are an equal opportunity employer. Thank you for your interest in growing your career with us.