Manager, Medical Writing (REMOTE)

Who we are

The opportunity

The Medical Writing Manager in Global Regulatory Medical Writing is responsible for writing and editing clinical regulatory documents, providing oversight and guidance, and managing resources for medical writing support in clinical research documentation used in drug development and product registration.

Travel Requirements: Up to 10% Domestic
Location: US-Based Remote (US Eastern time zone preferred)

How you’ll spend your day

• Writes and edits clinical regulatory documents (e.g., study reports, protocols, briefing books, investigator’s brochures, health authority responses, Module 2.5 and 2.7.x).
• Compiles, analyzes, and summarizes data.
• Proofreads, edits, formats documents, and resolves comments.
• Ensures regulatory compliance and scientific clarity.
• May contribute to SOPs and templates.
• May train/support writers or vendors.

Your experience and qualifications

Education:

• Required: Bachelor's in life sciences or related field
• Preferred: Master's, MD, PhD, PharmD

Experience:

• Required: 5+ years of relevant experience, 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)
• Preferred: 6+ years with an advanced degree, Lead author experience in at least 4 of the 6 document categories listed above

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

Compensation

The annual starting salary for this position is between $112,080 – 140,100 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Enjoy a more rewarding choice

We offer a competitive benefits package, including:

· 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.

· Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, 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 and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Reports To

Director, Therapy Area Head, Medical Writing

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