Senior Strategic Medical Writer

Job not on LinkedIn

🕒 September 19

🌽 Illinois – Remote

🌽 Illinois – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Lead and write clinical and regulatory documents for drug and/or device development in support of company objectives • Prepare clinical and regulatory documents needed for AbbVie drug and/or device development • Draft materials with moderate autonomy and incorporate review by subject matter experts and senior writers • Develop knowledge and understanding of submission strategies • Coordinate review, approval, and quality control across functions involved in clinical and regulatory projects • Arrange and conduct team review meetings • Produce and maintain high-quality, compliant clinical and regulatory documents within project timelines • Develop project management knowledge and take greater responsibility for driving submission objectives • Apply US and international regulations, requirements, and guidelines to regulatory documentation • Participate in tactical process improvements • Identify and propose solutions to issues arising during the writing process, resolving or escalating as appropriate • Work with leadership and R&D Quality Assurance to address inquiries and draft responses in support of an inspection-ready approach

🎯 Requirements

• Minimum of 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas • Bachelor's Degree or higher required; scientific discipline preferred • Outstanding written and oral communication skills • Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas • Proficiency in assimilating and analyzing complex data • Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements • Familiarity with CONSORT and PRISMA guidelines • Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology • EU and US device writing experience is a plus • Excellent writing skills • Ability to communicate complex scientific and medical information to various stakeholders • Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams • Strong organizational, time management, and problem-solving skills • Ability to sit continuously for prolonged periods, more than 2 consecutive hours in an 8-hour day

🏖️ Benefits

• Paid time off, including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in long-term incentive programs