insourcing solutions
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Technical Writer - Remote

Indianapolis Competitive p/h Contract

Job Responsibilities:

  • Review and refine technical documents for clarity, grammar, formatting, and compliance, ensuring all documentation is accurate, current, and meets established standards and SOPs.
  • Participate in process and equipment testing to gain a thorough understanding of the systems being documented.
  • Develop, update, and complete technical documents for regulatory submissions, ensuring they adhere to both local and international regulatory standards and guidelines.
  • Utilize effective technical writing methods to produce clear, concise, and thorough documentation.
  • Oversee the entire lifecycle of regulatory documents, including version control, archiving, and retrieval, while ensuring the integrity and confidentiality of sensitive information.
  • Ensure that all programs remain compliant with US and international regulatory bodies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
  • Work closely with subject matter experts (SMEs) from various departments to gather, interpret, and accurately present data in regulatory documents.


Qualifications:

  • Effective written and verbal communication skills, with the ability to collaborate with cross-functional teams.
  • Proven ability to manage time effectively and pay attention to detail.
  • Proficiency in document management systems and the Microsoft Office Suite. Familiarity with eCTD structure and requirements is desirable.
  • At least 3 years of relevant experience in technical writing.
  • Excellent proficiency in English communication, including grammar and composition.
  • Demonstrated understanding of GMP / cGMP regulations.
  • Capability to read, understand, and follow instructions accurately and safely.
  • Strongly preferred background in the pharmaceutical, biotechnology, or medical device industries.
  • Ability to work effectively both independently and as part of a team.
  • Bachelor's degree or equivalent work experience required.
  • Proven ability to handle and coordinate multiple projects in a dynamic and professional setting.
  • Preferably experienced in technical writing within a regulatory affairs context.


Contact your Recruiter:

For more information about the role and to express your interest, you can reach out to our recruiter, Zhanri, directly:

  • Email: zdesphy@harbasolutions.com
  • Phone: 617.284.4255


About Harba Solutions:

Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.

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