Director, Therapy Area Head, Medical Writing

Title: Director, Therapy Area Head, Medical Writing - REMOTE (EST/CST)

Location: United States

Job Description:

The opportunity

The Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, including submission summaries and other complex documents, provides a significant level of oversight and expert guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. The Director offers clear leadership and extensive accountability, strategic vision, and planning for clinical regulatory documents.

Travel Requirements: International and domestic
Location: US-Based Remote (US Eastern time zone preferred)

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. 

• Primarily works on the therapeutic area/functional level


• Likely to have direct reports; oversees contingent workers and/or vendors; provides training to others; strategically analyzes needs to manage resources and is accountable for resource allocation


• Oversees/mentors for all document types


• May write and edit clinical regulatory documents (all types)


• Ensures that documents include the proper context and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards


• Leads/recommends the preparation/revision of document templates


• Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans


• Responsible for tracking/providing metrics and established key performance indicators


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Your experience and qualifications

• PhD/PharmD with a minimum 8 years experience or a Master’s with a mnimum of 10 years experience


• Mastery of Microsoft Word


• Advanced regulatory medical writing expertise, strong writing/editing skills, knowledge of drug development regulations


• Global regulations and guidelines for document submissions


• Compensation Data

The annual starting salary for this position is between $177,680 - $233,205 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.

How We’ll Take Care of You 

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.