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Technical Writer/Data Reviewer

Company: Intarcia Therapeutics, Inc.
Location: Hayward
Posted on: June 15, 2019

Job Description:

Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.

At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.

Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System---, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.

We Are Growing--

Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston's Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.--

A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are - and intend to remain - the driving vision and force behind our progress and our ultimate success.

Your Opportunity:

As a key member of the Process Development Engineering team, the Technical Writer/Data Reviewer--is responsible for writing technical reports and regulatory documentation related to pharmaceutical product development activities. This role will also include data review of technical documents written by other authors. In order to perform in this role, the candidate will need to have the ability to understand engineering and scientific concepts associated with pharmaceutical development of drug products. The candidate will need to be capable of summarizing and analyzing experimental data followed by creation of succinct technical reports that follow standard scientific writing formats.

Duties and Responsibilities:


  • Produce high-quality technical reports related to CMC process development activities.
  • Support regulatory filings, including writing of CMC sections for INDs and NDAs.
  • Data review of technical documents written by other authors.

    Qualifications:


    • College degree in Engineering preferred.
    • 7+ years of experience in pharmaceutical R&D role.
    • Must be able to fluently speak and write in English.

      Skills and Experience:


      • Good writing and verbal communication skills.
      • Strong understanding of science and engineering concepts related to Pharmaceutical Development.
      • Knowledge of Regulatory requirements for pharmaceuticals and medical devices is a plus.
      • Attention to detail.
      • Strong working knowledge of Microsoft Office.
      • Working in cGMP environment.
      • Ambitious and positive attitude.

        (No relocation/Local candidates only)

Keywords: Intarcia Therapeutics, Inc., San Francisco , Technical Writer/Data Reviewer, IT / Software / Systems , Hayward, California

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