Document Analyst Jobs

Our client, a leading Pharmaceutical company, is hiring a Document Analyst on a contract basis.

Remote

Pay: $35-$37/hour

W2 Position Only

Summary:

Technical Writing and Document Management (TDM) function is responsible for delivering CMC documentation to support regulatory strategy for Cell therapy portfolio from early stage through life cycle management.

Document Specialist supports the documentation activities for regulatory submission content and supporting documentation for cell therapy portfolio. This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Development, Quality and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.

Responsibilities:

• Trains others on procedures as appropriate.
• Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
• Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
• Must possess the ability to support multiple projects simultaneously.
• Assist with dossier creation and system compliance for regulatory submissions.
• Participate in various cross-functional project teams, interact with SMEs, regulatory and other key partners both internal and external to the company as necessary.
• Facilitate data verification activities.
• Schedule authoring, review, approval tasks and consensus meetings with stakeholders (SMEs, GRS CMC, management).
• Works independently under supervision and collaborates with other teams.
• Manage the logistical process and detailed timeline for CTD Quality sections aligned with scientific/regulatory content creation for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions.
• Support SMEs with document editing for compliance with authoring style guide, Core template.
• Participate in initiatives involved with regulatory filings.
• Manage dossier content and agency questions delivery timelines aligned with global CMC submission timelines.

Qualifications:

• Bachelor’s degree or equivalent in relevant discipline with a minimum of 2 years’ experience.
• Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions.
• Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred.
• Familiarity with eCTD structure for regulatory submissions is required.
• Outstanding verbal and writing communication skills, attention to detail, strong planning, organizational and negotiating skills, with focus on timely delivery.
• Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Experience with regulatory documentation software is required along with proficiency in compliance ready standards for final publication is a strong asset.