Technical Editor I

Planet Pharma; South San Francisco (CA); Vor Ort; USD 55.000 - 70.000; Vollzeit

Zusammenfassung

Planet Pharma is seeking a contractor to support nonclinical document lifecycle management, data entry and workflow coordination for regulatory submissions.

You will ensure document accuracy, organize digital libraries, and collaborate with Submission Managers to deliver high‑quality, compliant documents meeting global regulatory standards.

Qualifikationen

• Bachelor's degree in English or science or related field
• At least 2 years in scientific editing or document management
• Knowledge of drug development and regulatory submissions
• Strong project management and organizational skills
• Detail-oriented with strong written and verbal communication
• Experience with AI-augmented tools is a plus
• Proficiency in MS Word

Aufgaben

• Build familiarity with internal processes, tools, and document management systems.
• Transfer and manage documents across digital libraries and folder structures.
• Capture, identify, and apply metadata to files and system records.
• Publish finalized documents and reports within the DMS.
• Perform QC to ensure readiness standards.
• Format and edit nonclinical documents to editorial standards.
• Retrieve missing information from archives.
• Initiate document records within tracking systems.
• Enter data and match documents to project plans.
• Develop timelines for deliverables and track completion.
• Coordinate document hand-offs across SMEs, authors, publishing and stakeholders.
• Identify problems and collaborate on solutions.
• Maintain internal team websites and portals.
• Create content and perform routine updates.
• Serve as editorial contact and communicate processes.

Kenntnisse

Scientific editing

Technical writing

Document management

Project management

Attention to detail

Communication skills

Ausbildung

B.A./B.S. degree

Tools

MS Word

AI tools

Jobbeschreibung

Job Description

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

• 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.
• 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.
• 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.
• 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.

• 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