Nonclinical Technical Writer

Pride Global; South San Francisco (CA); Vor Ort; USD 62.000 - 69.000; Vollzeit

Zusammenfassung

PrideGlobal is seeking a Nonclinical Technical Writer for a 12-month contract in South San Francisco, CA. The role is onsite with a pay range of $45-$50 per hour, depending on experience.

The ideal candidate will manage non-clinical documents, apply metadata, publish reports, and perform QC within document management systems. A biology/english background and at least 2 years of editing or document management experience are preferred.

Qualifikationen

• Bachelor’s degree in English, science, communications, liberal arts, health-related field, or a related discipline.
• Minimum 2 years of scientific editing, writing, or document management experience.
• Knowledge of the drug development process and regulatory submissions required.
• Strong project management and organizational skills.
• Strong written and verbal communication skills.
• Ability to manage multiple projects and meet aggressive deadlines.
• Strong attention to detail and document quality.
• Experience with AI-augmented tools and automation for documentation workflows is preferred.

Aufgaben

• Manage and process non-clinical documents across digital libraries and folder structures.
• Capture, identify, and apply accurate metadata to files and system records.
• Publish finalized documents and reports within document management systems.
• Perform QC and verification to ensure documents meet readiness standards.
• Format, edit, and track nonclinical documents, including study reports, GLP statements, CRO reports, and IND/BLA summaries.
• Retrieve missing information through historical archives and data research.
• Initiate document records and enter accurate system data.
• Track document deliverables, timelines, and completion status.
• Coordinate document hand-offs and review cycles across authors, subject matter experts, publishing teams, and stakeholders.
• Identify document or submission issues and collaborate with teams to develop solutions.
• Maintain internal team websites and portals and keep content up to date.
• Communicate documentation processes and serve as an editorial resource for team members and stakeholders.

Kenntnisse

Metadata tagging

Document management

Editing

QC processes

Ausbildung

Bachelor’s degree in English or related field

Tools

Microsoft Word

AI-augmented tools

Jobbeschreibung

$45-$50 per hour South San Francisco, CA Onsite

Share on

Job Description

Russell Tobin is partnering with a top biotech company to identify a Nonclinical Technical Writer professional for an opportunity in South San Francisco, CA.

Responsibilities

• Manage and process non-clinical documents across digital libraries and folder structures
• Capture, identify, and apply accurate metadata to files and system records
• Publish finalized documents and reports within document management systems
• Perform QC and verification to ensure documents meet readiness standards
• Format, edit, and track nonclinical documents, including study reports, GLP statements, CRO reports, and IND/BLA summaries
• Retrieve missing information through historical archives and data research
• Initiate document records and enter accurate system data
• Track document deliverables, timelines, and completion status
• Coordinate document hand-offs and review cycles across authors, subject matter experts, publishing teams, and stakeholders
• Identify document or submission issues and collaborate with teams to develop solutions
• Maintain internal team websites and portals and keep content up to date
• Communicate documentation processes and serve as an editorial resource for team members and stakeholders

Russell Tobin is partnering with a top biotech company to identify a Nonclinical Technical Writer professional for an opportunity in South San Francisco, CA.

Responsibilities

• Manage and process non-clinical documents across digital libraries and folder structures
• Capture, identify, and apply accurate metadata to files and system records
• Publish finalized documents and reports within document management systems
• Perform QC and verification to ensure documents meet readiness standards
• Format, edit, and track nonclinical documents, including study reports, GLP statements, CRO reports, and IND/BLA summaries
• Retrieve missing information through historical archives and data research
• Initiate document records and enter accurate system data
• Track document deliverables, timelines, and completion status
• Coordinate document hand-offs and review cycles across authors, subject matter experts, publishing teams, and stakeholders
• Identify document or submission issues and collaborate with teams to develop solutions
• Maintain internal team websites and portals and keep content up to date
• Communicate documentation processes and serve as an editorial resource for team members and stakeholders

Requirements

• Bachelor’s degree in English, science, communications, liberal arts, health-related field, or a related discipline
• Minimum 2 years of scientific editing, writing, or document management experience
• Knowledge of the drug development process and regulatory submissionsrequired
• Strong project management and organizational skills
• Strong written and verbal communication skills
• Ability to manage multiple projects and meet aggressive deadlines
• Strong attention to detail and document quality
• Ability to anticipate, troubleshoot, and resolve issues impacting timelines
• Proficiency with Microsoft Word
• Experience with AI-augmented tools and automation for documentation workflows is preferred

Additional Details

• Location model: South San Francisco, CA 94080
• Position Type: 12-month contract with potential to extend
• Pay range approved: $45-$50/hr depending on experience

For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity

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.

Fair Chance Employment

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.