Senior Regulatory Writing Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the functional area leader within product teams.

• Spearhead writing efforts for intricate product submissions.

• Draft or supervise the creation of regulatory submission documents, such as 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.

• Perform formal reviews and approvals of authored documents in alignment with relevant standard operating procedures.

• Direct regulatory writing efforts for complex product submissions, encompassing new and supplemental drug applications and biologics license applications.

• Provide expertise in the functional area and contribute to Global Regulatory Plans and team objectives.

• Engage with Global Regulatory, Evidence Generation, Global Safety, and Label Working Group teams.

• Oversee contract and freelance writers while mentoring junior medical writers.

• Lead initiatives both within the department and across departments.

• Develop timelines for document generation.

⛳️ Requirements

• Doctorate degree with 2 years of directly relevant experience, or Master’s degree with 6 years, or Bachelor’s degree with 8 years, or Associate’s degree with 10 years, or a high school diploma/GED with 12 years of experience.

• Familiarity with regulatory documents in Regulatory Affairs, Research, Development, or a related field.

• Over 5 years of experience in medical writing within the biotechnology or pharmaceutical sector.

• Capability to lead regulatory writing efforts for complex product submissions.

• Understanding of regulatory submission documents and relevant standard operating procedures.

• Experience in serving as a functional area lead on product teams.

• Proven experience in supervising contract and freelance writers and mentoring junior medical writers.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan featuring generous company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Bi-annual company-wide shutdowns.

• Flexible work arrangements, including remote options where feasible.

• Opportunities for career development.

• Emphasis on work/life balance.