Technical Writer

4 days ago


United Kingdom Apex Systems Full time

Role: Technical Writer

Location: Remote (UK/EU)

Duration: 5 month contact



Summary: Apex Systems is seeking multiple Technical Writers with a Pharma/Biotech regulatory compliance background, to support a migration project with a large global Pharma organization.


Responsibilities:

- Understand how procedural documents are structured and what is required

- Coordinate/deliver assigned procedural documents through the lifecycle or SOP/WI draft and authoring.

- Draft SOP/WI and partner with business SMEs to assure process inputs are in line with functional requirements

- Ensure documents are completed on-time and to the required standard for approval

- Facilitate conversations/decision making activity to drive resolution across many SMEs for each document, ensuring document is accurate and meets quality guideline.

- Able to work within a project environment, coordinating across multiple document deliverables and SME discussions


Qualifications:

- Minimum of 5 years of experience with regulatory writing in a pharmaceutical/biotech setting

- Understanding of industry regulation compliance

- Experience understanding and writing SOP's

- Experience with Veeva RIM preferred

- Exceptional written and verbal communication skills, strong technical writing abilities, and the ability to work independently and collaboratively on multiple projects.


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