represent Medical Writing and provide leadership in one or more compound areas
oversee junior writers and assist in leading regulatory submissions
manage and develop staff, including performance management and training
write all in-scope clinical documentation in their compound areas
lead all MW deliverable work for assigned compounds/indications
manage work of both internal and outsourced Medical Writers
work with clinical team to develop document strategy and write in-scope deliverables as needed
develop and articulate document strategy and timelines
identify appropriate decision makers, focus on results/actions
lead regulatory submissions/submission document writing
participate in process improvement initiatives and new initiatives within MW and throughout Global Development
manage processes and organize priorities; solve problems; foster collaboration to resolve conflict
challenge and develop MW team
ensure adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area

Requirements

bachelor’s degree required, advanced degree preferred
minimum of 8 years’ relevant Medical Writing experience (relevant advanced degree may offset some of the experience requirement)
expert knowledge of the clinical research process and regulations/guidelines and regulatory writing
expert clinical document reading, writing, and editing experience
proficiency in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
thorough understanding of ICH GCP guidelines
experience managing medical writers is helpful

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical writingregulatory submissionsclinical documentationdocument strategyclinical research processregulatory writingclinical document readingclinical document writingeditingperformance management

Soft Skills

leadershipstaff developmentproblem solvingcollaborationconflict resolutionorganizational skillsfocus on resultstraining