job summary: Technical Writer II Job Summary
This role is supporting Medical Devices at the client
location: Lexington, Massachusetts
job type: Contract
salary: $34.31 - 40.37 per hour
work hours: 8 to 4
responsibilities: Job Responsibilities
- Under the direction of the line manager and DDL, the Technical Writer is responsible for preparation of high quality device/combination product regulatory submissions and a wide range of supporting documentation across the device development lifecycle including:
- pipeline programs (IMPD/CTA/IND)
- Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for informationn
- Briefing Books
- Post- Approval changes or compliance updates across all global franchises.
- In addition the Technical Writer will also be expected to drive, support and contribute to broader improvement initiatives that contribute to the client's overall success.
- This person will support the "submission"
- They need a tech writer to do drafting
- They need this writing to be consistent according to their SOP's and they need to make sure their documents a flowing and look uniform
- These are the submissions to the FDA and they need the tech writer to come in and make sure the submissions are "uniform" and all written the same way
- Tech writer is supposed to harmonize these documents so they flow correctly and look like they were written by the same individual
- This person needs to understand the content and make sure it's cohesive
qualifications: Education & Qualifications
- Biotech/pharma is preferred
- Someone coming from devices (med devices) would be fine too
- Submissions experience and writing experience
- 5-8 years would be sufficient
- Systems: mainly client specific so they will be trained when they start as long as they know Microsoft and know formatting
skills: Editing, IND, NDA, SOP, FDA, Maa, CTA, JNDA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.