Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Senior Principal Medical Writer – Regulatory, Oncology

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany Site LinkedIn

Location

Arizona + 4 more

Posted

166 days ago

Salary

$114K - $210.9K / year

Seniority

Senior

Bachelor DegreeEnglish

Job Description

• Develop regulatory documents for submission to regulatory agencies globally • Manage medical writing projects, including developing timelines and communication with cross-functional team members • Participate in cross-functional meetings to provide input regarding medical writing deliverables • Review other documents associated with the assigned project(s) • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects • Mentor more junior medical writing staff

Job Requirements

Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes
Manage medical writing projects, including developing timelines and communication with cross-functional team members
Participate in cross-functional meetings to provide input regarding medical writing deliverables
Review other documents associated with the assigned project(s)
Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents
Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
Mentor more junior medical writing staff

Benefits

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time