Job Description Our large pharmaceutical client in Spring House, PA is seeking a Validation Reporting Specialist to join the PK Assay team within the Bioanalytical Discovery and Development Sciences Department. The PK Assay Validation position will provide both writing (75%) and lab support (25%) to the Bioanalytical Discovery and Development Sciences Department for the transfer of PK methods to external partners. Responsibilities include validation sample preparation as well as drafting and finalizing method validation reports and supplemental documentation. This role will work independently to write and format documents according to the J&J submission standards. Responsibilities also include navigating reports through electronic workflows for scientific/compliance reviews and approvals. Core responsibilities:  Ensures the appropriate formatting of internal and external documents such as validation protocols and validation reports as directed by supervisor, or other clinical personnel.  Works with outsourcing team to support transfer of methods to external labs.  Ensures quality and accuracy of documents through proofreading and application of correct formatting and performing grammar/spell checks.  Prepare and document validation samples for use in method validations.  Works with outsourcing group to plan and support method cross-validations.  Assists in creating and updating document templates.  Ensures documents are produced in accordance with procedures, guidelines, and electronic templates for future inclusion in submissions.  Navigates documents through the review and approval workflows.  Organizes and incorporates information for documents, such as references, graphics, tables, and data listings. Checks and verifies hyperlinks, bookmarks, etc. Resolves errors to the correct destination. We 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: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements -Minimum of a Bachelors Degree in Biology or a related field of study -2+ years of method validation report writing experience within a regulated laboratory environment -Strong attention to detail -Experience with PK Assays -Scientific writing -GxP lab experience null We 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.