Nonclinical Document Management (Nonclinical Docs/Medical Writing)

Russell Tobin; United States; Remote; USD 62,000 - 69,000; Full time

Job summary

Russell Tobin is partnering with a pharmaceutical organization to identify a contractor for Nonclinical Document Management & Workflow Support to assist regulatory documentation and submission activities. This role focuses on document lifecycle management, scientific editing, workflow coordination, and ensuring accurate, compliant nonclinical documents for regulatory submissions.

The position is 100% remote as a 1-year contract with potential for extension, paying $45–$50 per hour depending

Qualifications

• Bachelor's degree in English, Science, Communications, Liberal Arts, or a health-related field.
• Minimum 2 years of experience in scientific editing, medical writing, or document management.
• Knowledge of the drug development process and regulatory submissions is mandatory.
• Proficiency in Microsoft Word and document formatting.
• Experience with AI-assisted tools and workflow automation is preferred.

Responsibilities

• Manage nonclinical documents across digital libraries and DMS with accurate filing and metadata.
• Perform quality checks, editing, formatting, and verification for accuracy and completeness.
• Review and track nonclinical study reports, GLP statements, CRO reports, and IND/BLA submission summaries.
• Create document records and update tracking systems aligned with project plans.
• Coordinate timelines, handoffs, and review cycles among authors, SMEs, publishing teams, and regulatory stakeholders.
• Retrieve missing information from archives and resolve documentation issues.
• Maintain internal team websites and portals, including content updates.
• Collaborate with cross-functional teams to ensure timely, compliant deliverables and AI-assisted workflow improvements.

Skills

Document editing

Document management

Project management

Regulatory writing support

AI-assisted tools experience

Education

Bachelor's degree in English/Science/Communications or health-related field

Tools

Microsoft Word

Job description

Nonclinical Document Management & Workflow Support | Medical Writing | Regulatory Documentation

Russell Tobin is partnering with a Pharmaceutical organization to identify a Contractor, Nonclinical Document Management & Workflow Support to support regulatory documentation and submission activities. This role focuses on document lifecycle management, scientific editing, workflow coordination, and ensuring accurate, compliant nonclinical documents for regulatory submissions.

Responsibilities

• Manage nonclinical documents across digital libraries and document management systems, ensuring accurate filing and metadata entry.
• Perform quality checks, editing, formatting, and verification to ensure document accuracy, completeness, and consistency.
• Review and track nonclinical study reports, GLP statements, CRO reports, and IND/BLA submission summaries.
• Create document records, update tracking systems, and align documents with project plans and submission requirements.
• Coordinate document timelines, handoffs, and review cycles among authors, subject matter experts, publishing teams, and regulatory stakeholders.
• Retrieve missing information from historical archives and resolve documentation issues.
• Maintain internal team websites and portals, including content creation and updates.
• Collaborate with cross-functional teams to ensure timely, compliant deliverables and improve workflows using AI-enabled tools and automation.

Requirements

• Bachelor's degree in English, Science, Communications, Liberal Arts, or a health-related field.
• Minimum 2 years of experience in scientific editing, medical writing, technical writing, or document management.
• Knowledge of the drug development process and regulatory submissions is mandatory.
• Proficiency in Microsoft Word and document formatting.
• Strong project management, organizational, and problem-solving skills.
• Excellent written and verbal communication skills with exceptional attention to detail.
• Ability to manage multiple projects, meet tight deadlines, and work effectively in a collaborative environment.
• Experience with AI-assisted tools and workflow automation is preferred.

• Location model: 100% Remote
• Position Type: 1-year contract with possibilities of extension
• Pay range approved: $45–$50/hr, depending on experience.

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates:

Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions:

For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.