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
• 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

• Required: Bachelor's in life sciences or related field
• Mastery of Microsoft Word
• Familiarity with Veeva Vault and other electronic formats
• Solid writing/editing skills
• Understanding of global regulatory guidelines and AMA style
• Familiarity with drug development, therapeutic areas, and statistical concepts
• 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

Director, Therapy Area Head, Medical Writing

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)

• 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
• 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