• The Senior Manager in Global Regulatory Medical Writing writes and edits clinical regulatory documents, including submission summaries and other complex documents
• They provide intermediate-level oversight and guidance, as well as resource management for direct medical-writing support in producing clinical research documentation used in drug development and product registrations
• 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 product/program level
• Possible to have direct reports; possible to oversee contingent workers and/or vendors; likely to provide training to others; and analyzes needs to manage resources
• Offers leadership and fundamental accountability, provides strategic supervision, and planning assistance for clinical regulatory documents
• Writes and edits clinical regulatory documents (all types)

Ensures that documents include the proper content 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 Participates in the preparation/revision of document templates

• PhD/PharmD with a minimum 4 years experience or a Master’s with a mnimum of 6 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

• The annual starting salary for this position is between $123,840 - $162,540 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