Senior Manager, Medical Writing

🕒 July 22

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

✏️ Content Writer

👻 Ghost score 51%

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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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 of 4-10 resources • Consult on and compose scientific, educational, research, and regulatory documents for Medical Writing client projects • Break down complex concepts and medical terminology for specific target audiences • Lead programs and prepare Phase I through IV and post-marketing regulatory documents • Prepare 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 abstracts/manuscripts for publication • Ensure peer review and quality control of regulatory documents for publishing 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 departments • Lead preparation and review of departmental SOPs to improve process efficiency and quality • Participate in RFIs and RFPs for business development opportunities

🎯 Requirements

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

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid Time Off) OR 20 days PTO • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs