Technical Writer - III Job at Careerbuilder-US, Atlanta, GA

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  • Careerbuilder-US
  • Atlanta, GA

Job Description

Our Client, a Biopharmaceutical company, is looking for a Technical Writer – III for their Santa Monica, CA location.

Responsibilities:

  • Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts
  • Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.

Requirements:

  • Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience
  • Experience CMC/Module 3 regulatory submissions
  • Experience in technical writing and proficient in high quality writing
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development
  • Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is highly desired
  • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
  • Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices
  • Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills and fluent with Microsoft office applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Careerbuilder-US

Job Tags

Temporary work,

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