Global Regulatory Writing Expert
4 weeks ago
As a Global Regulatory Writing Expert at Lifelancer, you will play a crucial role in authoring and gaining approval of scientific and regulatory submission documents that comply with global regulatory standards.
Maintaining key business relationships with cross-functional product team members is essential for success in this position. This role may also serve as a functional area lead on product teams, manage writing activities for product submissions, train and mentor junior writers, and assist with departmental activities.
Key Responsibilities:- Author 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, Pediatric Investigation Plans, and other regulatory documents;
- Conduct formal review and approval of authored documents, following applicable standard operating procedures;
- Manage regulatory writing activities for 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 input for Global Regulatory Plan and team goals;
- Work with contract and freelance writers;
- Participate in training and mentoring of junior medical writers;
- Participate in departmental and cross-departmental initiatives, as appropriate.
To succeed as a Global Regulatory Writing Expert, you must have:
- Proficiency with word processing and other Microsoft Office Programs;
- Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;
- Ability to understand and follow complex standard operating procedures (SOP's), guidance documents, and work instructions;
- Understanding and application of principles, concepts, theories, and standards of scientific/technical field;
- Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and requirements;
The ideal candidate will have:
- Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma/GED and 12 years of directly related experience;
- Experience with regulatory documents in Regulatory Affairs, Research, Development, or related areas;
- 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry.
The estimated annual salary for this position is $120,000-$150,000, depending on experience and qualifications. As a valued member of the Lifelancer team, you will enjoy a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Lifelancer is an Equal Opportunity employer and welcomes diverse candidates from all backgrounds.
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