What are the responsibilities and job description for the Documentation Analyst position at Eclaro?
Documentation Analyst
Job Number: 25-03748
Job Number: 25-03748
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Documentation Analyst for our client in New Brunswick, NJ (Remote).
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- This role will be responsible for managing the documentation activities for marketing applications and / or post-approval regulatory submissions for cell therapy brands.
- This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and / or post-approval regulatory submissions for cell therapy brands.
- This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments.
- This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time.
- This consultant is expected to have a good understanding of regulatory guidelines.
Responsibilities:
- Manage document preparation of CMC regulatory submission documents to Client standards and ensure final document compliance to ensure submission content meets formatting requirements.
- Manage the logistical process in the authoring system for CMC regulatory submissions.
- This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling / facilitating consensus meetings, distributing review comments to the matrix teams.
- Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure.
- Author CMC elements of regulatory filings with supervision.
- Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.
Required Qualifications:
- Bachelor’s Degree in a relevant discipline with a minimum of 4 - 7 years relevant experience or a Master’s Degree with 1-3 years relevant experience.
- Possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams.
- Possess excellent time management and organizational skills and have the ability to navigate in electronic systems.
- Possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
- Must be highly flexible and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines.
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
212-804-7476
June Binuya | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
