Medical Device Documentation
We are a small, new to market medical device company located in the us. We have a class 1 medical device (non-sterile non measuring).We are in need of help with our technical file. We have spent quite a lot of time on this file but need someone to either finish it for us or direct us what to do next.
+29 Other ResponsesTechnical Writer Gxp Process
This is a contract opportunity in california: technical writer gxp process
overview:
the technical writer will primarily be responsible for working with internal it and other gxp partners to identify content needs, develop, revise, format and publish standard operating procedures (sops), work instructions (wis} and validation documentations. Additionally, the consultant will assist by supporting the it function with incident management, ca/pa (corrective action and preventative action), audit management, change management and vendor management processes.
Responsibilities:
-author sops, wis and forms in compliance with our documentation management process and procedures.
-work with staff to define business requirements and process solutions.
-work closely with it and functional subject matter experts (smes} to determine the content for sops, wis and forms.
-participate in review sessions of sops, wis, and forms to incorporate comments and/or changes, as applicable.
-complete assignments in accordance with set standards related to format, order, clarity, conciseness, style and terminology.
-provide status updates on all documentation milestones.
-work with project teams to identify, analyze, prioritize, document and communicate project risks to mitigate impact to project deliverables and timeline.
Qualifications:
-must possess the ability to quickly develop and maintain a high level of knowledge and understanding of our existing solutions and documentation.
-requires an understanding of cfr part 11 and gamp5 provisions as they apply to systems management and deployment.
-must be resourceful with a strong customer-service orientation and commitment to provide timely and quality solutions to customer issues.
-demonstrated excellent written and verbal communication skills. An effective listener able to convey information in an accurate and concise manner and understands when to seek feedback.
-effective presentation skills with the ability to deliver information to a broad range of audience.
-must be well-organized, self-directed, and a team player.
-highly effective in prioritizing and organizing work plans and activities to deliver on objectives on time and within budget.
-must be detail oriented, with strong analytical and problem solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems.
-must possess a strong understanding of business processes related to pharmaceutical corporate activities
contact us here on zintro for further details.
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