Technical Writer

Beacon Hill - Job Details
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Technical Writer

St. Louis, Missouri

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Full Time Temporary/Contract

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NA

St. Louis, Missouri

Full Time Temporary/Contract

NA

July 01, 2024

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Job ID: NJN1373325_1719878050

July 01, 2024

Job ID: NJN1373325_1719878050

Job Summary

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Summary of Position

The Regulatory Affairs Technical Writer supports projects related to Company's business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products. This position focuses on the creation, revision, and maintenance of technical documentation necessary for regulatory submissions and compliance within a regulated industry, such as pharmaceuticals, biotechnology, or medical devices. A keen attention to detail, strong writing skills, and the ability to synthesize complex information into clear, concise, and compliant documentation are essential.

Essential Functions

  • Draft, revise, and finalize technical documents required for regulatory submissions, ensuring compliance with local and international regulatory standards and guidelines.
  • Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
  • Work closely with subject matter experts (SMEs) across various departments to gather, interpret, and accurately represent data and information in regulatory documents.
  • Participate in process and equipment testing to learn systems being documented.
  • Review and edit technical documents for clarity, grammar, format, and compliance. Ensure all documentation is accurate, up-to-date, and adheres to established standards and SOPs.
  • Manage the lifecycle of regulatory documents, including version control, archiving, and retrieval. Ensure the integrity and confidentiality of sensitive information.
  • All programs must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

  • Bachelor Degree or equivalent work experience required.
  • 3 or more years of relevant experience in technical writing required.
  • Experience with technical writing in a regulatory affairs environment preferred.
  • Experience in the pharmaceutical, biotechnology, or medical device industry is highly preferred.
  • Must be able to communicate clearly in English and have solid communication skills including grammar and composition.
  • Demonstrated understanding of GMP / cGMP regulations.
  • Skill in communication, written and verbal with the ability to interact with cross-functional teams.
  • Proven time management skills and a strong attention to detail.
  • Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
  • Ability to work well with others and independently.
  • Able to read, understand and follow work instructions in a safe, accurate and timely manner.
  • Proficiency in document management systems and Microsoft Office Suite. Familiarity with eCTD structure and requirements is desirable.

NJN1373325_1719878050

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™