Manager, Medical Writing

Job not on LinkedIn

September 25

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

💵 $112.1k - $140.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

🦅 H1B Visa Sponsor

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Teva Pharmaceuticals

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Healthcare • Pharmaceuticals • Biotechnology

Teva Pharmaceuticals is a global leader in the pharmaceutical industry, specializing in the development, production, and marketing of generic and specialty medicines. They are dedicated to providing quality healthcare solutions to patients around the world, emphasizing innovation and access to effective medications. With a strong commitment to sustainability, Teva aims to improve health outcomes through their diverse portfolio of products and services.

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

💰 Post-IPO Equity on 2023-11

📋 Description

• Write and edit clinical regulatory documents (e.g., study reports, protocols, briefing books, investigator’s brochures, health authority responses, Module 2.5 and 2.7.x). • Compile, analyze, and summarize clinical data for regulatory documents. • Proofread, edit, format documents, and resolve comments to ensure regulatory compliance and scientific clarity. • Provide oversight, guidance, and manage resources for medical writing support in clinical research documentation used in drug development and product registration. • Contribute to SOPs and templates and may train/support writers or vendors. • Lead document development processes and meetings and communicate with cross-functional teams and regulatory authorities. • Track project timelines, manage deliverables, escalate issues, and contribute to process improvement and budget planning. • Report to Director, Therapy Area Head, Medical Writing.

🎯 Requirements

• Education: Bachelor's in life sciences or related field required; Master's, MD, PhD, PharmD preferred. • Experience: 5+ years of relevant experience required; 6+ years preferred with an advanced degree. • Lead author experience in: protocols/protocol amendments, clinical study reports, investigator’s brochures, clinical summary documents (Modules 2.5, 2.7.1–2.7.4) (required to be lead author for several document types). • Technical Skills: Mastery of Microsoft Word; familiarity with Veeva Vault and other electronic formats. • Knowledge: solid writing/editing skills; understanding of global regulatory guidelines and AMA style; familiarity with drug development, therapeutic areas, and statistical concepts. • Job-Specific Competencies: Excellent written and spoken English; strong interpersonal, critical thinking, and administrative skills; ability to lead document development processes and meetings; effective communication with cross-functional teams and regulatory authorities; project management and timeline tracking; problem-solving and escalation; contribution to process improvement and budget planning. • Travel: Up to 10% domestic travel. • Location/time preference: US-Based Remote (US Eastern time zone preferred).

🏖️ Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. • Life and Disability Protection: Company paid Life and Disability insurance. • Employee Assistance Program. • Employee Stock Purchase Plan. • Tuition Assistance. • Flexible Spending Accounts and Health Savings Account. • Life Style Spending Account. • Volunteer Time Off. • Paid Parental Leave (if eligible). • Family Building Benefits. • Virtual Physical Therapy. • Accident, Critical Illness and Hospital Indemnity Insurances. • Identity Theft Protection. • Legal Plan. • Voluntary Life Insurance and Long Term Disability. • Potential restricted stock units and discretionary awards.