
Global Regulatory Lead
2 days ago
Job Overview:
The position of Global Regulatory Writing Manager is a leadership role that oversees the development and submission of regulatory documents. This includes Clinical Study Reports, Investigator Brochures, and other critical documents.
This key leader will guide a team of writers to ensure timely completion of high-quality documents. A strong understanding of scientific and technical writing principles, as well as expertise in standard operating procedures and clinical development processes, are required for success in this role.
- Develop regulatory submission documents, including Clinical Study Reports, Investigator Brochures, 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.
- Lead functional area teams on product initiatives, providing input for Global Regulatory Plans and team goals.
Required Qualifications:
- Doctorate degree OR Master's degree with 4-6 years of experience OR Bachelor's degree with 6-8 years of experience OR Diploma with 10-12 years of experience.
- Proficiency in word processing and Microsoft Office Programs.
- Significant knowledge of scientific/technical writing and editing, and overall clinical development process for new compounds.
- Ability to understand and follow complex standard operating procedures (SOPs), guidance documents, and work instructions.
Preferred Qualifications:
- Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
- Excellent written/oral communication skills and attention to detail.
- Ability to demonstrate leadership in a team environment, requiring negotiation, persuasion, collaboration, and analytical judgment.
- Proficient time and project management skills.
About the Role:
This position offers an excellent opportunity for experienced professionals to take on a leadership role and contribute to the success of our organization. If you have a passion for regulatory writing and want to make a meaningful impact, we encourage you to apply.
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