Job Title: Documentation Analyst
Location: Remote
Job Summary:
- Join our team as a Documentation Analyst, where you’ll manage documentation activities for marketing applications and post-approval regulatory submissions for cell therapy brands. You’ll collaborate with various departments, ensuring quality regulatory submissions are delivered on time.
Job Responsibilities:
- Oversee the preparation of CMC regulatory submission documents, ensuring compliance with company standards and formatting requirements.
- Handle the logistical process in the authoring system for CMC regulatory submissions, including coordinating reviews and facilitating consensus meetings.
- Facilitate data verification to ensure accuracy of submission data following internal standard operating procedures.
- Author CMC elements of regulatory filings under supervision.
- Participate in cross-functional project teams, interacting with technical subject matter experts, regulatory, and other key partners.
Skills Required:
- Bachelor’s degree in a relevant discipline with 4 – 7 years of experience, or a Master’s degree with 1-3 years of experience.
- Ability to work both independently and collaboratively in a team environment.
- Excellent time management and organizational skills.
- Proficiency in navigating electronic systems.
- Working knowledge of regulatory CMC submissions; experience in Cell Therapy and CMC is a plus.
- High flexibility and ability to manage multiple projects in a fast-paced, changing environment, and deliver on deadlines.
About SSi People:
With over 26 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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