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Insight Global

Pharmaceutical Technical Writer_

Insight Global, Philadelphia, Pennsylvania, United States,


Job DescriptionOne of our large biotech companies is seeking a skilled and detail-oriented Technical Writer to join their dynamic team on a large project which is in the Pharmaceutical / Bio-technical industry. This role is crucial for supporting large capital projects by developing high-quality documentation that meets regulatory, company, and stakeholder standards. Ideal candidates will have a strongbackground in technical writing within the pharmaceutical or biotech sectors and be adept at managing complex information and project deadlines. Responsibilities will include:Create, revise, and maintain clear, concise technical documentation including but not limitedto User Requirements Specifications, Maintenance and Operational SOPs, PreventativeMaintenance (PM) Plans, Work Instructions, Bill Of Materials Lists.Work closely with Project Leads, Site Engineering, Process Engineering, AutomationEngineering, Facilities / Maintenance and Metrology to gather the necessary information toproduce technical content within the documentation.Ensure all documentation is compliant with industry standards, regulatory requirements, andinternal guidelines.Participate in project meetings to understand project scope, milestones, and deliverables.Coordinate the review, approval, and change management processes for all project-relateddocuments with cross functional departments.As necessary develop templates and standards for future documentation to ensureconsistency and efficiency.Provide input on document design and layout to enhance readability and user engagement.Utilize document management systems to track and manage revisions and approvals.Support technical data migration into appropriate electronic systems. (Engineering system,CMMS, Validation system) as appropriate.Adapt content for diverse audiences, ranging from technical experts to non-technicalstakeholdersWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: om/workforce-privacy-policy/ .Skills and RequirementsBachelors degree in Technical field, English, Communications, or a related field.Proven experience (8+ years) as a technical writer, preferably in the cGMP Pharmaceutical orequivalent biotechnology industry.Familiarity with regulatory compliance environments such as FDA, EMA, ICH, ISPE and USPguidelines. nullWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.