Technical Writer I (Temporary)

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Job Description

Purpose and ScopePerform technical writing as part of a project team to optimize batch records. Restructure and reformat batch records to improve record flow and reduce the number of entries. Work closely with the batch record team to incorporate feedback from stakeholder departments. Participate in project team meetings to make live edits and provide recommendations for improvement. Work independently to revise batch records based on template established by the project team.The anticipated duration of the assignment is six months. Remote arrangement possible.Essential Duties & ResponsibilitiesUse Word to revise and restructure batch records per the generic established template.Interact closely with the batch record team to improve record flow and reduce the number of entries.After developing the record type templates with the project team, work independently to revise the remaining records in the group.Resolve annotations in the electronic document management system (Veeva).Assist in resolving annotations, routing, and tracking of documents for approval in the electronic document management system (Veeva).Work closely with technical writer on the counterpart team to ensure all document revisions are consistent.Perform other related duties as assigned.Core ValuesThe Technical Writer I is expected to operate within the framework of Tolmar’s Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart of our company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.Knowledge, Skills & AbilitiesBasic knowledge of cGMP guidelines and application to manufacturing.Very strong knowledge of word processing, graphics and spreadsheet programs.Excellent organizational, interpersonal, and leadership skills.Strong oral and written communication skills.Excellent ability to multi-task and adjust to changing priorities.Ability to work on short and long-term projects simultaneously and meet timelines.Ability to work well independently and with others.Education & ExperienceBachelor’s degree in Science, English, Journalism or related field.Two or more years of technical writing in a controlled manufacturing field (pharmaceutical, biotech, or medical device preferred)Working ConditionsApproximately 3 days a week on site in office setting or synchronous via WebEx.2 days a week working remotely. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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Fort Collins, Colorado Location
Permanent Job Type