Senior Manager, Medical Writing

🕒 August 7

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Manage the Medical Writing team and consult on and compose scientific, educational, research, and regulatory documents for client projects • Break down complex concepts and medical terminology for specific target audiences • Lead teams and manage projects to deliver quality documents on time, within quality standards, and within department budget • Provide leadership and management of the Medical Writing group • Lead programs and prepare Phase 1 through IV and post-marketing regulatory documents, including clinical protocols and study reports, study synopses, IND, NDA and MAA submission documents, safety narratives, registry and observational study protocols and reports, REMS assessment reports, KABS reports, and publication abstracts/manuscripts • Ensure peer review and quality control of regulatory documents according to SOPs • Participate in UBC and client project teams for project planning and timeline development • Coordinate and consult with SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management • Lead preparation and review of departmental SOPs • Participate in RFIs and RFPs for business development opportunities • Supervise a team of 4–10 medical writers

🎯 Requirements

• Master's or doctorate degree in biological sciences or equivalent • 10–15 years of experience, with at least 8 years in medical regulatory writing or equivalent within the pharmaceutical/CRO industry • Broad experience across multiple therapeutic areas and phases of clinical studies • Leadership experience managing a medical writing team • Advanced Microsoft Word skills • Advanced Adobe Pro skills • Familiarity with different document management systems • Knowledge of medical terminology and the clinical trial process • Knowledge of REMS and KAB regulatory programs preferred • Ability to interpret clinical data • Strong analytical skills • Ability to communicate with cross-functional teams • Strong leadership and organizational skills • Attention to detail and high degree of accuracy • Strong communication and interpersonal skills