Regulatory Affairs Writer Job

REGULATORY AFFAIRS WRITER needed for a CONTRACT opportunity with Yoh's client located in THOUSAND OAKS, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Supports Biosimilars staff with the preparation of regulatory filings, including briefing documents, INDs, IMPDs, CTAs, BLAs, MAAs, and responses to queries.
- Provides writing expertise while interfacing and collaborating cross-functionally with Analytical Sciences, Regulatory Affairs, Clinical Operations, various other teams, and contract services, as directed, to develop authoring plans and strategic approaches for document development and timelines.
- Provides a strong working knowledge of regulatory (US FDA, EMA, PMDA, ICH) guidelines and applies these guidelines to projects and submissions.
- Independently plans, drafts, and finalizes scientific, CMC (quality), nonclinical, clinical, and regulatory documents that conform to global requirements, the client and industry standards, and accepted templates within specified timelines in support of product registrations and global filings.
- Works within the clients systems for document management.
- When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
- This position will be required to administer the processing of documents via the established Document Processing Review process.
- May require communication through a variety of media (eg, CD, Intranet, on-line training, etc.)

WHAT YOU NEED TO BRING TO THE TABLE:

- MS Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills.
- Preferred qualifications also include attention to detail
- Ability to work under tight timelines both independently and within a team
- Ability to self-organize, coordinate, and prioritize multiple tasks with competing activities across several parallel projects
- Strong team skills with a commitment to customer service and good business ethics
- Strong interpersonal skill
- Experience in writing laboratory reports
- Ability to analyze data
- Capability to discern areas of potential concern and to communicate concerns effectively to manager.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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