CMC Technical Writer, Biologics Job

CMC TECHNICAL WRITER, BIOLOGICS needed for a CONTRACT opportunity with Yoh's client located in Cranbury, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- CMC Regulatory writing
- Drug development process
- Global CMC regulatory requirements

WHAT YOU'LL BE DOING:

- Author and/or review CMC sections of original regulatory dossier submissions (eg CTAs, INDs, BLAs, MAAs), amendments, supplements, annual reports, etc.
- Work closely with other functional areas within the Company (eg Quality, Manufacturing ) for the preparation and compilation of CMC sections of regulatory dossiers.
- Maintain full awareness of all CMC regulatory activities on assigned projects to assure that the project deadlines and performance standards for these projects are met.
- Manage document writing and finalization within approved timelines.
- Provide writing support for other technical reports and regulatory documents as required

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum Bachelor degree in scientific discipline (Chemistry, Pharmacy, Biology, etc.).
- 5-10 years relevant pharmaceutical experience with at least 3 years of experience in CMC regulatory writing, preferably for biologics and sterile products.
- Understand the drug development process, especially CMC development requirements for biologics products.
- Demonstrated experience in electronic submission requirements.
- Knowledge and expertise in preparation of CTAs, INDs, and NDAs (BLAs) in CTD format.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Ability to support and effectively multi-task different and complex assignments and responsibilities
- Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint.
- Excellent knowledge of the English language and strong writing, proofreading, and spelling skills.
- Knowledge of CMC regulations as related to the development of biosimilar products will be a plus.
- Knowledge of global (US, EU, etc.) CMC regulatory requirements for biologics and combination drug products a plus.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Hannah Cihlar

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAXTERM: CON_W2J2WMIDATL

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