Lead R&D Technical Writer

Job Title: Lead R&D Technical Writer
Location: Portage, MI
Type: Contract
Compensation: $60-65.21/hr
Work Model: Remote – offsite


Be part of a forward-thinking healthcare and medical device environment where your expertise directly supports the development of life-changing technologies. This contract role offers the opportunity to independently lead and support clinical and regulatory documentation efforts, influence documentation standards and processes, and collaborate across teams to deliver high-quality submissions on schedule. Ideal candidates bring strong technical writing or documentation experience, exceptional attention to detail, and the ability to manage complex deliverables in a regulated environment.

Responsibilities

• Assist in the timely development and completion of clinical reports, summary documents, package inserts, and other documents.
• May oversee the electronic regulatory submission process.
• Oversee and provide recommendations for the development of formats and guidelines for documentation.
• Provide guidance and direction for the completion and development of clinical and pre-clinical documents.
• Ensure effective planning and management of timelines for all aspects of technical documents.
• This is an individual contributor role that requires judgment in applying professional expertise and working independently with minimal supervision.
• Utilize professional mastery of a specialized field, typically requiring a college degree or equivalent.
• Apply principles and concepts of own subject/technical discipline to resolve issues as they arise.
• Maintain attention to detail in making evaluative judgments based on the analysis of factual information.
• Leverage applicable work experience, generally a minimum of 4 years, to support responsibilities.

• Professional mastery of a specialized field of expertise.
• Minimum of 4 years' relevant work experience.
• College degree or equivalent required.
• Experience in clinical or pre-clinical documentation preferred.
• Knowledge of electronic regulatory submission processes is a plus.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific