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Senior Technical Writer

Company Description:

Infostretch is a pure-play digital engineering services firm focused on helping companies accelerate their digital initiatives from strategy and planning through execution. We leverage deep technical expertise, Agile methodologies and data-driven intelligence to modernize systems of engagement and simplify human/tech interaction. We deliver custom solutions that meet customers’ technology needs wherever they are in their digital lifecycle. Backed by Goldman Sachs and Everstone Capital, Infostretch works with both large enterprises and emerging innovators -- putting digital to work to enable new products and business models, engage with customers in new ways, and create sustainable competitive differentiation.

  • Tools & Technologies:
    - Development experience in cloud technologies will be good
    - 4-6 years of writing experience in the medical or pharmaceutical industry. Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills.
  • Other skills:
    Excellent written and verbal communication skills.
    Experience with collaborative, cross-functional teams.
    Excellent analytical skills and ability to manage complex tasks and manage time effectively.
  • Project/Work Details:
    1. Understanding of auditing to standards or regulations such as the FDA Quality System Regulation (must have), ISO 9001, ISO 13485, ISO 14971, IEC 62304 (Good to have)
    2. Ensure timely production of high-quality documents required for RA/QA activities.
    3. Supports additional clinical, regulatory, quality, and engineering-related deliverables as assigned.
    4. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources including literature, clinical data, and medical references.
    5. Authors and contributes to necessary documents for regulatory submissions and communications.
    6. Ensures quality in all deliverables and documentation with attention to detail, consistency, and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures.
    7. Work and collaborate with cross-functional groups within product development to ensure the relevant documents can be put together.

Disclaimer:
If you feel that this is a good match for your skillsets, please submit a current word version of your resume along with a cover letter describing your skills, experience and salary expectations. We are an Equal Opportunity Employer (EOE). You can read our job applicant privacy policy here.

Apply Online Print

Job Code: ED-AP-210423

Category: Engineering

Job Type: Full-Time

Location: Pune, India or Ahmedabad, India

Open Positions: 1

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