![]() ![]() ![]() Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to write high quality documents according to tight timelines.Įxperience working with Electronic Data Management Systems (EDMS)Įxcellent interpersonal skills and attention to detail. *Special knowledge or skills and/or licenses or certificates preferred.īroad knowledge of ICH guidelines, FDA CFRs, EMA directives and other regulatory guidelines. Proficiency with Microsoft Office and use of electronic document templates.Įxcellent verbal and written communication skills.Ībility to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Strong technical comprehension and writing capability.Įxperience with inProcess mapping and collaborative document development.Įxcellent attention to detail, including fact checking, logical flow, formatting, and document structure. * Special knowledge or skills needed and/or licenses or certificates required.Ībility to plan, write, review, and edit technical GxP documents (SOPs, Work Instructions, forms, checklists, manuals, and training quizzes) and ensure that these documents adhere to applicable regulatory FDA, EMA, ICH guidelines and standards.Įxperience in working in a GXP environment. * Minimum level of education and years of relevant work experience.īachelor’s degree in a scientific discipline and a minimum of 5 years of technical GxP document writing experience (SOPs, Work Instructions, forms, checklists, manuals, and training quizzes) in the pharmaceutical, biotechnology, contract research organization or related environment/industry, or recognized equivalent of education and experience (minimum level of education required – Associates degree.) ![]() Performs other related tasks and assignments as needed and specified by management related to document generation and control. The Contract SOP/Technical Writer, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Ĭollaborates with GxP SMEs and teams to write, review or edit technical GxP documents (SOPs, Work Instructions, forms, checklists, manuals, and training quizzes) in a clear, concise format.Įnsures good documentation practices are followed.Ĭoordinates with various departments to assure GxP document written are indicative of the process and understandable to the reader.Īcts as liaison between QA and the department that the document is being written for. The incumbent works cross-functionally with internal departments and external resources on GxP related procedural documents. The Contract SOP/Technical Writer is responsible for applying appropriate document templates, standards, style and terminology across documents. This involves collecting and consolidating input from cross functional stakeholders, developing process maps, reviewing current GxP regulatory requirements (ICH guidelines, FDA CFRs, EMA directives, etc.) company SOPs and developing them into clear and concise procedures. The Contract SOP/Technical Writer, supports the System Document Management processes by collaborating with authors and Subject Matter Experts (SMEs) to revise or create SOPs, Work Instructions, forms, checklists, manuals, and training quizzes.
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