Senior Document Specialist

This is a fully remote position, open to applicants in Texas.

📋 Description

• Supervise, coordinate, and gather appendix documents in Veeva Vault for submission to regulatory bodies alongside clinical study reports.

• Ensure that documents meet both domestic and international regulatory submission standards as well as internal documentation requirements.

• Develop high-quality, scientifically precise binders in accordance with ICH guidelines and strict deadlines.

• Ensure adherence to Medical Writing conventions, processes, and regulatory standards.

• Oversee appendix collection schedules and communicate expectations, milestones, and deliverables to Medical Writers and cross-functional teams.

• Import, export, initiate, and approve workflows in Veeva Vault as part of the Report Level Content Plan.

• Conduct quality checks and authorize appendix documents.

• Serve as Document Coordinator for SOP or WI updates and author documents within the Document Specialist scope.

• Engage in training related to medical writing, document types, and drug and biologic development.

• Collaborate within the Global Medical Writing department.

⛳️ Requirements

• Proven ability to communicate in clear, concise, and effective English, both in writing and verbally.

• Capacity to prioritize tasks, manage multiple projects, and adhere to tight deadlines and changing priorities.

• Comprehensive understanding of regulatory submission requirements as outlined by FDA regulations and ICH guidelines.

• Preferably familiar with drug and biologic development processes, including clinical study design, biostatistics, regulatory affairs, and medical terminology.

• Experience in project management, delivering presentations, and leading meetings.

• Strong problem-solving abilities and self-driven motivation.

• Exceptional interpersonal skills, self-awareness, inclusivity, and teamwork capabilities.

• Required education: Master’s degree; or BA/BS with 2+ years of relevant industry experience; or 5+ years of hands-on training and experience, including document management and process implementation, in the pharmaceutical or biotech sectors.

• Technical proficiency in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat.

• Familiarity with electronic document management systems.

• Proficient in Microsoft Windows and Veeva Vault.

• Knowledge of SharePoint file systems is advantageous.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan.

• FSA/HSA options.

• Life insurance.

• Paid Time Off.

• Wellness benefits.

• Option for remote work.

• Occasional travel as needed.