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Sr. Biotechnologist/RA Specialist, Frederick, MD
Our client is seeking a Sr. Biotechnologist/RA Specialist for a contract to hire opportunity in Frederick, MD.
Citizenship Requirements: US Citizens ONLY due to government client requirements.
Currently remote due to COVID, however once restrictions are lifted, will be on-site in Frederick, MD with some telecommuting allowed.
- Provide technical writing, editing, and formatting of drafts and related materials for all sections of regulatory applications under the guidance and support of senior RA staff.
- Review submissions for accuracy and verification of chemistry, manufacturing and controls (CMC), clinical, and nonclinical data.
- Perform critical review of regulatory documents for writing standards, logic, content, presentation and clarity.
- Perform QC review of publishing outputs to meet eCTD publishing guidelines.
- Coordinate with senior RA staff to develop timelines for regulatory submissions and to coordinate with multi-disciplinary teams to execute to those timelines.
- Conduct Regulatory Intelligence activities, as assigned.
- Minimum 3 years of experience in the bio-pharmaceutical industry with writing/review of regulatory documentation (INDs, batch production records, amendments, BLAs, safety reports, supplements).
- Minimum 3 year of cGMP experience in the bio-pharmaceutical industry.Or at least 2 years of experience as a RA Specialist (if promoting from within).
- RAC Certified is desirable, but not mandatory.
- Excellent computer skills to include MS Office, MS Word, Excel, PowerPoint, Adobe, Visio.
- Excellent verbal and written communications skills, editing and organizational skills.
- Ability to work well independently, multi-task between projects and remain flexible.
- Only those individuals selected for an interview will be contacted.
- No calls, inquiries, or Third Party Vendors please.
- We are an equal opportunity employer (Unable to sponsor H1B Visas).
- $1000 Referral Bonus - www.aci.com.
Since 1988, The ACI Group, a Baltimore-based IT staffing firm, has been committed to hiring the industry’s leading professionals, and presenting exciting career opportunities. We have access to varied types of contract, permanent and contract-to-perm positions and offer a choice of employment options including a full benefits package.
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