Senior Medical Writer

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $117k - $189.2k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Author and support medical writing content, including clinical protocols and amendments, Investigator Brochures, clinical study reports, agency requests for information, IND/CTA submission documents, NDA/MAA clinical modules and summary documents, and other writing as necessary • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management teams • Partner with internal and external writers to support document completion • Oversee document preparation from kick-off and planning through drafting, review cycles, feedback incorporation, revisions, quality control and quality assurance findings, and final delivery within timelines • Ensure clarity, consistency, and proper formatting of clinical documents across programs • Maintain compliance with GCP, ICH, eCTD, and company guidelines • Interpret complex clinical data and information • Demonstrate strategic thinking and review capabilities • Contribute to developing and improving SOPs, templates, and document standards • Report to the Director, Medical Writing Operations

🎯 Requirements

• PhD or advanced degree in a scientific or clinical discipline • 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing • Previous neuroscience experience strongly preferred • Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines • Flexibility and comfortability with evolving priorities and targets • Understanding of drug development, biostatistics, and medical terminology • Basic understanding of scientific methodology as applied to drug development • Knowledge of global clinical trials and regulatory submission requirements, including FDA, EMA, PMDA, ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations • Proficiency in Microsoft Word advanced features • Familiarity with document management and collaborative authoring platforms such as Veeva Vault and Please Review • Ability to work independently and collaboratively in a dynamic, fast-paced, cross-functional environment • Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups open to all employees