Regulatory Publisher Job at Pharmatech Associates in Los Angeles

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world.

Typical Project Responsibilities include :

• Manage the end-to-end publishing (preparation through delivery) of regulatory submissions (e.g., INDs, NDAs, BLAs) in electronic and paper formats according to US FDA requirements.
• Ensures compliance in document formatting, PDF specifications and eCTD formatting of submission components.
• Ensure compliance with document management systems and version control procedures for regulatory submissions.
• Coordinate with internal and client project team as needed for publishing and submission-related issues and activities.
• Compiling, reviewing, processing, and approving submission documents for format compliance including, but not limited to : amendments / supplements, annual reports, study protocols, briefing packages, and CMC updates.
• Providing advanced MS Word and template training / guidance and troubleshooting support to authors and subject matter experts.
• Creating or reviewing publishing standards and style guides.

Qualifications and Experience :

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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