Senior Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and support medical writing materials, which include clinical protocols and amendments, Investigator Brochures, clinical study reports, agency information requests, IND/CTA submission documents, NDA/MAA clinical modules and summary documents, as well as any additional writing as required.

• Collaborate effectively with teams in Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management.

• Work in partnership with both internal and external writers to facilitate document completion.

• Manage document preparation from the initial kick-off and planning stages through drafting, review cycles, incorporation of feedback, quality control, quality assurance findings, and final delivery.

• Ensure that clinical documents maintain clarity, consistency, and proper formatting across all programs.

• Uphold compliance with GCP, ICH, eCTD, and company policies.

• Analyze complex clinical data and information.

• Exhibit strategic thinking and review capabilities.

• Assist in the development and enhancement of SOPs, templates, and document standards.

⛳️ Requirements

• PhD or an advanced degree in a scientific or clinical field.

• A minimum of 4 years of experience in medical writing or a related role within the pharmaceutical industry.

• At least 2 years of experience in sponsor-level clinical/regulatory medical writing.

• Prior experience in neuroscience is highly preferred.

• Knowledge of drug development processes, biostatistics, medical terminology, and scientific methodologies as they relate to drug development.

• Familiarity with global clinical trials and regulatory submission standards, including those set by FDA, EMA, PMDA, ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations.

• Proficient in Microsoft Word, particularly with advanced features.

• Experience with document management and collaborative authoring platforms like Veeva Vault and Please Review.

• Capacity to work both independently and as part of a team in a dynamic, fast-paced, cross-functional environment.

• Strong organizational, communication, and influencing abilities, with the capacity to prioritize, multitask, and produce high-quality documents within tight deadlines.

• Adaptability and comfort with changing priorities and objectives.

• Highly accurate, detail-oriented, and professional demeanor, complemented by excellent interpersonal skills and a calm, diplomatic approach to challenges.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence provisions.

• Well-being benefits, including an employee assistance program, fitness benefits, and various employee clubs and activities.

• Employee resource groups available to all employees.