Senior Medical Writer

🔥 15 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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 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, quality control and quality assurance findings, and final delivery • 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

🎯 Requirements

• PhD or advanced degree in a scientific or clinical discipline • 4+ years of medical writing or relevant pharmaceutical industry experience • At least 2 years in sponsor-level clinical/regulatory medical writing • Previous neuroscience experience strongly preferred • Understanding of drug development, biostatistics, medical terminology, and 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, including 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 • 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 • Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges

🏖️ Benefits

• Company bonus depending partly 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 • 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