Job Description:

Contractor, Nonclinical Document Management & Workflow Support.

Role Overview:

The contractor will provide essential support for document lifecycle management, data entry, and workflow coordination for nonclinical documents supporting various regulatory submission types. This role focuses on ensuring document accuracy, maintaining organized digital libraries, and collaborating across functional groups. The contractor will work closely with Submission Managers and serve as a resource to project and submission teams (such as Pharmacology Subteams) to ensure the timely delivery of high-quality, compliant documents that meet global regulatory standards.

Key Responsibilities:

Document Management & Processing:

Build familiarity with internal processes, tools, and document management systems, seeking guidance from experienced submission managers as needed.
Transfer and manage documents across various digital libraries and folder structures.
Accurately capture, identify, and apply metadata to files and system records.
Publish finalized documents and reports within the document management system.

Quality Control & Editing:

Perform quality control (QC) and verification of documents to ensure they meet readiness standards.
Format, edit, and track nonclinical documents (e.g., nonclinical study reports, GLP statements, CRO reports, IND/BLA summaries), applying established editorial standards and templates to ensure accuracy, completeness, and internal consistency.
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

Pharmaceutical Company

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