Regulatory Writing Senior Manager

Thousand Oaks, California

Job Title: Regulatory Writing Senior Manager

Location: Remote

Competitive Compensation: $53/hr – $55/hr

Are you a seasoned regulatory writer with a passion for excellence and a knack for leading complex submissions? Join our dynamic leader in the biotech and pharmaceutical industry, as our Regulatory Writing Senior Manager. We are seeking a detail-oriented professional to author and oversee critical regulatory documents, lead cross-functional teams, and mentor the next generation of medical writers.
Key responsibilities:

  • Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
  • Conduct the formal review and approval of authored documents, following applicable standard operating procedures
  • With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
  • Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
  • Provide functional area input for Global Regulatory Plan and team goals
  • Supervise the work of contract and freelance writers and mentor junior medical writers as
  • assigned
  • Lead departmental and cross-departmental initiatives, as appropriate
  • Generate document timelines

Required Qualifications:

  • Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred
  • Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
  • 5+years of experience in medical writing in the Biotech/Pharmaceutical industry

If you are ready to take on a challenging and rewarding role, we would love to hear from you! Apply Now!

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 



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