Director, Therapy Area Head, Medical Writing

TherapistTherapistFull TimeRemoteLeadTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

165 days ago

Salary

Not specified

Seniority

Lead

Postgraduate Degree8 yrs expExperience acceptedEnglish

Job Description

• 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 • Offers clear leadership and extensive accountability, strategic vision, and planning for clinical regulatory documents

Job Requirements

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

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.
  • 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.

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