Principal Medical Writer

Alnylam Pharmaceuticals; Cambridge; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Principal Medical Writer to join their dynamic team in a hybrid role. This position offers the opportunity to contribute to the development of critical clinical documents while collaborating with multi-disciplinary teams. You will leverage your extensive experience in medical writing and regulatory submissions to produce high-quality documents and lead key projects. This innovative firm values commitment to people and excellence, providing a supportive environment for professional growth. If you're passionate about making a difference in the medical field, this role is perfect for you.

Qualifications

• 7+ years of experience as a medical writer in sponsor/CRO settings.
• In-depth knowledge of GCP, FDA regulations, and ICH guidelines.

Responsibilities

• Produce high-quality clinical documents and manage review processes.
• Collaborate with various departments and external stakeholders.

Skills

Medical Writing

Regulatory Submissions

Project Management

GCP Knowledge

Microsoft Office Suite

Education

Bachelor's degree in Life Science

Advanced degree or certification

Tools

eCTD Formatting

EDMS Systems

Job description

This is a hybrid role based in Cambridge, MA. The selected candidate must commit to working on-site at least 2 days per week. Remote candidates will not be considered.

Position Overview

The Principal Medical Writer represents medical writing on multi-disciplinary teams, collaborates on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs), and oversees the work of internal and contract writers. This is an individual contributor position, equivalent to the Associate Director, without direct report responsibilities.

Responsibilities

1. Produce high-quality and on-time clinical documents
2. Independently plan, coordinate, develop, update, and revise key documents, including clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, and related documents.
3. Lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses to questions independently
4. Provide medical writing subject matter expertise and leadership to project teams, collaborating with Medical Writing line management for planning and resourcing
5. Facilitate/manage review and finalization processes for documents produced internally and externally by consultants, contractors, and vendors
6. Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, and other departments, as well as external stakeholders
7. Contribute to the development and standardization of templates and processes, and assist in staff training
8. Provide oversight for post-approval regulatory documents, such as PASS and non-interventional protocols
9. Assist line managers in training and developing junior staff

Qualifications

1. Bachelor's degree in Life Science or English/Communications with relevant science expertise; advanced degree or certification preferred
2. 7+ years of experience as a medical writer in sponsor/CRO settings, with experience in regulatory submissions (NDA/BLA/MAA) preferred
3. Experience with MW processes, standards, and overseeing contract writers
4. In-depth knowledge of GCP, FDA regulations, ICH guidelines, and drug development
5. Proven ability to manage multiple projects in a fast-paced environment
6. Knowledge of eCTD formatting and EDMS systems preferred
7. Proficiency with Microsoft Office Suite
8. Alignment with Alnylam Core Values: Commitment to People, Innovation, Purposeful Urgency, Open Culture, Passion for Excellence