IVD Devices Technical Writer
Budget: $1,500 – $3,000 USD
I'm looking for a professional technical writer to provide high-quality assistance in the creation and revision of technical documents for my Research and Development Department/IVD Devices Manufacturing Department. Our aim is to ensure that all our documents are thoroughly checked and meet IVD quality standards and regulations.
Key Accountabilities :
- Create and revise Technical Documents including Protocols, Reports, Design
- Input Requirements, and other Technical Documents related to Product Development and Design Control, and Manufacturing.
- Manage the revision of design control documents; ensure the accuracy, adequacy and consistency of documents.
- Collaborate with multidisciplinary teams to understand different aspects of Product Development and provide writing knowledge to the Design Control documents to ensure compliance with IVD standards.
- Work with Subject Matter Experts (SMEs) to gather information to create or revise documents.
- Assist with maintaining the design history file (DHF) to ensure Documentation is up to date and accurate.
- Ensure all technical documentation is clear, concise, and compliant with regulatory requirements.
- Manage multiple writing projects simultaneously, ensuring timely completion and adherence to project deadlines.
Networking/Key relationships : Mainly with R&D/Manufacturing, Regulatory Affairs and Design Quality colleagues.
Minimum Knowledge & Experience required for the position:
- Bachelor's degree in the biological or related sciences - Required
- Any additional degree higher than the required (advanced degree (Master’s or PhD) in a relevant scientific field) - Preferable
- Valuable knowledge of Quality Standards and of EU and US regulatory requirements for IVDs.
- At least three (3) years of experience with technical, scientific, or medical writing in an in vitro diagnostic environment, a biotechnology company environment, a pharmaceutical environment, an academic medical environment, or the equivalent.
Language: Fluency in English (reading, speaking and writing).
Skills & Capabilities:
- Thorough knowledge of Design Control processes and familiarity with Quality Standards as required.
- Strong attention to detail and accuracy.
- Oral and written communication skills.
- Ability to adapt to R&D flexible and changing environment
- Teamwork and interpersonal skills. Flexibility in order to work with, and provide support for a number of people.
- Time management skills. Excellent organizational and multi-tasking skills.
- Excellent analytical skills.
- Able to work independently with moderate guidance.
Key Accountabilities :
- Create and revise Technical Documents including Protocols, Reports, Design
- Input Requirements, and other Technical Documents related to Product Development and Design Control, and Manufacturing.
- Manage the revision of design control documents; ensure the accuracy, adequacy and consistency of documents.
- Collaborate with multidisciplinary teams to understand different aspects of Product Development and provide writing knowledge to the Design Control documents to ensure compliance with IVD standards.
- Work with Subject Matter Experts (SMEs) to gather information to create or revise documents.
- Assist with maintaining the design history file (DHF) to ensure Documentation is up to date and accurate.
- Ensure all technical documentation is clear, concise, and compliant with regulatory requirements.
- Manage multiple writing projects simultaneously, ensuring timely completion and adherence to project deadlines.
Networking/Key relationships : Mainly with R&D/Manufacturing, Regulatory Affairs and Design Quality colleagues.
Minimum Knowledge & Experience required for the position:
- Bachelor's degree in the biological or related sciences - Required
- Any additional degree higher than the required (advanced degree (Master’s or PhD) in a relevant scientific field) - Preferable
- Valuable knowledge of Quality Standards and of EU and US regulatory requirements for IVDs.
- At least three (3) years of experience with technical, scientific, or medical writing in an in vitro diagnostic environment, a biotechnology company environment, a pharmaceutical environment, an academic medical environment, or the equivalent.
Language: Fluency in English (reading, speaking and writing).
Skills & Capabilities:
- Thorough knowledge of Design Control processes and familiarity with Quality Standards as required.
- Strong attention to detail and accuracy.
- Oral and written communication skills.
- Ability to adapt to R&D flexible and changing environment
- Teamwork and interpersonal skills. Flexibility in order to work with, and provide support for a number of people.
- Time management skills. Excellent organizational and multi-tasking skills.
- Excellent analytical skills.
- Able to work independently with moderate guidance.