Summary:

The Senior Regulatory Document Formatting Specialist, in Regulatory Operations, will format and finalize documents for regulatory submissions. The ideal candidate will have experience formatting complex documents, in-depth understanding of Microsoft Word and Adobe Acrobat Pro, and experience with using document templates. This role will assist with regulatory submission planning, preparation, and review to ensure high quality, timely submission of regulatory filings to health authorities.

Essential Functions:

Ideal candidates should be able to produce high quality documents within established time frames. Job activities include:

• Formatting and compiling documents using Word to create and update tables of contents, add headers/footers and table and figure titles, insert figures, create bookmarks and links, split multiple-page tables, use track changes and comment functions.
• Working in a collaborative authoring environment (Veeva RIM).
• Reviewing documents to ensure that formatting is consistent throughout documents in accordance with internal templates and style guide (use of abbreviations, in-text citations, hyperlinks, terminology, bibliographies, etc.).
• Maintaining the list of literature for regulatory submissions and obtaining copies of literature, as needed.
• Communicating effectively with the Regulatory team and other functional groups, as needed, to meet project timelines.
• Assisting with Regulatory Operations’ efforts to implement and improve systems, processes, and tools.

Requirements:

College degree, AA/AS or BA/BS with a minimum of 5 years of experience in Regulatory Operations with formatting/word processing regulatory documents. Other combinations of education and/or experience may be considered.

• Proficient with Word, Adobe Acrobat Pro, PowerPoint, and Excel.
• Familiar with using Veeva RIM for authoring and reviewing documents is preferred.
• Experience with using OmniTemplates is a plus.
• Good understanding of the CTD structure and Clinical documents (Protocols, Clinical Study Reports, Statistical Analysis Plans, etc.) in accordance with regulatory guidelines
• Accustomed to fast-paced, highly regulated environment with the ability to work independently.
• Accountable, adaptable, and dependable.
• Sound business ethics, including the protection of proprietary and confidential information, is required.
• Excellent attention to detail and organizational/time-management skills.
• Works well with others.

Reports to: Manager, Regulatory Operations

Location: San Carlos, CA or Remote

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (minimum of 2-3 days per week onsite) or Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $112,000 – $131,000 (SF Bay Area). Salary ranges for non-California locations may vary.