Retrieve missing information by searching through historical archives and tracking down data.
System Workflow & Coordination
Initiate document records within the tracking and document management systems.
Enter system data and accurately match documents to broader project plans.
Assess and develop timelines for document deliverables, supporting authors by tracking the completion of documents.
Manage collaborations by coordinating document hand-offs and review cycles between subject matter experts, authors, publishing teams, and stakeholders in Development Sciences, Regulatory Affairs, and other functions.
Identify problems with documents or submissions and collaborate with the team to develop effective solutions.
Internal Communications & Content Management
Manage and maintain internal team websites or portals.
Create new content and perform routine updates to ensure information remains current.
Serve as an editorial contact and communicate documentation processes to team members and stakeholders.
Qualifications
Education: B.A./B.S. degree in English, science, communications, liberal arts, or a health-related field.
Experience: Minimum of 2 years of scientific editing, writing, or document management experience.
Skills
Knowledge of the drug development process and regulatory submissions is mandatory.
Strong project management and organizational skills is mandatory .
Ability to anticipate and solve issues impacting timelines.
Ability to work concurrently on multiple projects, meet aggressive deadlines, and contribute effectively in a fast-paced, highly collaborative team environment.
Strong written and verbal communication, solutions-focused mindset.
High attention to detail to prevent inaccurate or substandard documents that could lead to submission corrections or delays.
Experience leveraging AI-augmented tools and automation to streamline documentation workflows and enhance overall efficiency is preferred.
Profiency with MS Word
Pay Rate Range: 40-51/hr depending on experience
