Technical Writer V

3 weeks ago

Durham, United States TalentBurst, an Inc 5000 company Full time

Industry: Biotechnology Research

Position: Technical Writer V

Job ID: OASKB0000548

Location: Research Triangle Park, NC (Hybrid: 2/3 days per week remote)

Duration: 04 months contract (+Possibility of extension)

Working Hours: 30/week


Job Description:

We are a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

We've built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson's disease, and congestive heart failure. Our gene therapy platform includes Pro10TM, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.


Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.


Our principles:

  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need.
  • Provide an environment for employees to reach their fullest potential.


Our values:

  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.


Position Overview

The Technical Writer, reporting to the Director of Facilities will be responsible for writing and developing Standard Operating Procedures (SOPs) and other process documents for the Facilities and Engineering (F&E) department. This position is eligible for hybrid or possibly fully remote work.


Responsibilities

  • Collaborate with subject matter experts (SMEs) within the Engineering Department to gather information and understand processes while translating workflows into procedures.
  • Write, revise, and coordinate the maintenance of SOPs, work instructions, training documents and other procedures in accordance with regulatory requirements and industry standards.
  • Ensure clarity, accuracy, and consistency in all documentation produced, adhering to company templates and guidelines.
  • Conduct thorough reviews of documents to ensure compliance with internal standards and stated goals and a coherent flow of information.
  • Work closely with cross-functional teams, including Quality Assurance, Laboratory Managers, and F&E management to gather feedback and incorporate changes as needed.


Education and Experience

  • Bachelor's degree in a scientific or engineering field or equivalent formal academic / vocational experience is required.
  • Proven experience as a technical writer, preferably in the pharmaceutical or biotechnology industry.
  • Familiarity with maintenance workflows, particularly as they relate to computerized maintenance management systems (CMMS).
  • Ability to translate processes and requirements into technical documentation.
  • Excellent writing, editing, and proofreading skills with keen attention to detail.
  • Strong understanding of regulatory requirements, including FDA and GMP.
  • Experience with process mapping and flowcharting tools.
  • Proficiency with document management systems and Microsoft Office Suite.
  • Strong communication and interpersonal skills with the ability to interact effectively with diverse stakeholders.

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