Business Professional – Lead Analyst, R&D Technical Writing (Individual Contributor) - Minnesota, United States - 174692

Description and Requirements

Job Title: Business Professional – Lead Analyst, R&D Technical Writing (Individual Contributor)

Work Location: Minnesota (Virtual / Remote)

Employment Type: Contract (7 months)
Pay Rate: $50/hour

Job Overview:

We are seeking an experienced Lead Analyst – R&D Technical Writing to support the development, management, and completion of critical clinical and regulatory documentation. This role plays a key part in ensuring high-quality, compliant, and timely preparation of clinical reports, summary documents, package inserts, and other regulatory materials.

This is an individual contributor role requiring strong independent judgment, advanced technical writing expertise, and the ability to manage complex documentation tasks with minimal supervision.

Key Responsibilities:

Develop, write, and complete clinical reports, summary documents, package inserts, and other regulatory documentation
Support and/or oversee electronic regulatory submission processes as required
Establish, refine, and recommend documentation formats, templates, and writing guidelines to ensure consistency and compliance
Provide guidance and direction in the preparation of clinical and pre-clinical documents
Plan, manage, and track timelines for all assigned technical documentation deliverables
Ensure accuracy, clarity, and compliance through detailed review and evaluation of technical and factual information
Collaborate with cross-functional teams including R&D, Clinical, Regulatory, and other stakeholders
Apply professional expertise to independently resolve documentation and content-related issues as they arise

Qualifications:

Bachelor’s degree in a relevant discipline or equivalent professional experience
Minimum of 4+ years of experience in technical writing, regulatory writing, clinical documentation, or related R&D support roles
Strong understanding of clinical and/or pre-clinical documentation standards and regulatory submission processes
Ability to work independently with minimal supervision in an individual contributor capacity
Excellent attention to detail and strong analytical skills in evaluating technical and factual information
Strong organizational skills with the ability to manage multiple deadlines and priorities
Excellent written communication skills with the ability to produce clear, structured, and compliant documentation