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Job Description

Our large pharmaceutical client is seeking a Laboratory Report Specialist to join their growing team in Spring House, PA (hybrid schedule). The Report Specialist will provide writing and data analytics support to the Bioanalytical Discovery and Development Sciences Department within R&D in a fully electronic global database (RIMDocs) system for writing, reviewing, and finalizing all bioanalytical reports, technical reports, qualification summary reports and method validation reports. This role will work independently to assist scientists, scientific leaders, and external partners to pull data from multiple systems and then write and format reports according to the submission standards. Primary responsibilities include: Navigate reports through electronic workflows for scientific/compliance reviews, electronic signatures, and regulatory submission preparation; Assist in creating submission ready templates; Apply relevant internal standards, regulatory, and publishing guidelines to submission, internal reporting, external reporting, and documentation. This role has a hybrid schedule that requires this individual to be onsite 3 days a week in Spring House, PA. Other responsibilities include:

Pulling and analyzing data from LIMS and RIMDOCS to create reports and documentation for the Bioanalytical Discovery & Development teams

Work hand in hand with scientific teams to revise and prepare method validation and technical reports, document templates and regulatory submissions

Ensures the appropriate formatting of internal and external documents such as Bioanalytical Reports, technical reports, and validation reports as directed by supervisor, the medical writers and other clinical or research personnel.

Draft bioanalytical reports and ensures documents are produced in accordance with procedures, guidelines, and electronic templates

Navigate documents through the review and approval workflows.

Ensures quality and accuracy of documents through proofreading and application of correct formatting and performing grammar/spell checks.

Works with analysts and within data repositories (i.e., LIMs, OpenLab, ELN, etc.) to create appropriate content.

Assists in training of Bioanalytical Discovery and Development Sciences Department staff on appropriate use of reporting systems and electronic templates.

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 [email protected] 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

Bachelor’s Degree in Biology, Biological Sciences, or a related field of study

2+ years of GMP Laboratory Report and Scientific writing experience

Prior experience drafting validation reports

Prior experience working hands on in the laboratory

Experience with LIMS and/or ELN systems