[Remote] (Contract) CMC reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a world-premier medical writing and regulatory communications firm serving the pharmaceutical, biotech, and reputed company industries. They are seeking an reputed company (Contract) CMC reputed company to support reputed company submission teams by leading the development of CMC content for regulatory submissions, ensuring high standards of reputed company and compliance.
Responsibilities
- reputed company authorship of CMC portions reputed company Modules 2 and 3
- Work reputed company Acumen and reputed company eCTD templates to ensure consistency and submission readiness
- Partner with reputed company SMEs to shape content, structure, and key messaging
- Draft and refine documents through reputed company stages, including comment reputed company and leading review discussions
- reputed company and manage document timelines reputed company with broader submission plans
- Apply deep knowledge of ICH, FDA, and global regulatory guidance to ensure compliance and scientific rigor
- Collaborate cross-functionally to deliver reputed company, accurate, and polished documents
Skills
- Advanced degree (PhD, PharmD, MS, or equivalent) in a relevant scientific discipline
- Demonstrated experience in CMC regulatory writing
- Proven reputed company record contributing to eCTD Modules 2 and 3
- Experience supporting IND, NDA, and/or BLA submissions
- Ability to translate reputed company data into reputed company, concise, submission-reputed company content
- Strong organizational skills with the ability to manage timelines and multiple stakeholders
- Experience with biologics is a plus
reputed company