Senior Manager, Medical Writing

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October 23

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CultureHQ

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SaaS

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1 - 10 employees

Founded 2017

☁️ SaaS

📋 Description

• Lead planning, authoring, reviewing, and QC of clinical and regulatory documents • Facilitate document reviews and lead consensus meetings among stakeholders • Ensure consistent messaging across documents • Represent Medical Writing department on clinical study teams • Perform/manage quality control reviews of clinical and regulatory documents • Collaborate with/manage contract writers • Contribute to development/implementation of medical writing processes • Adhere to regulatory standards and company SOPs

🎯 Requirements

• Bachelor’s degree • 5+ years of medical writing experience for Manager position; 7+ years for Senior Manager position or fewer years with advanced degree (MS, PhD, MD, PharmD) • Strong knowledge of FDA and ICH guidelines, GCP, and regulatory processes related to document preparation • Proficient in researching scientific literature and distilling complex topics clearly • Strong project management and time management skills • Excellent interpersonal, written, and verbal communication skills • Self-motivated and effective in working with cross-functional teams • Strong computer and software skills (Word, Excel, PowerPoint, Adobe suite, Veeva RIM, SharePoint) • Experience as a key contributor or lead author for submissions of regulatory documents is preferred

🏖️ Benefits

• Health insurance • 401(k) plan • Stock options • Performance-based bonus • Competitive time-off • Commuter/parking benefits