Technical Writer

2 days ago

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Iovance Biotherapeutics, Inc.

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Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000

Description

• The Technical Writer is responsible for creating, reviewing, and editing technical documents. • Own and investigate Supply Chain related deviations, working with cross-functional stakeholders. • Work closely with subject matter experts to gather technical information and create documentation. • Develop, manage, track and maintain change control documentation. • Oversee the creation, revision, and approval of GMP compliant labels for products. • Lead and perform Root Cause Analysis on Supply Chain deviations. • Ensure all documentation is compliant with internal and regulatory requirements. • Collaborate in a team environment or work independently as required.

Requirements

• Bachelor's degree, with a minimum 3+ years of experience in technical writing, preferably in the biotechnology industry. • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed. • Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required. • Ability to build relationships quickly and credibly across departments and a variety of personalities and experience levels. • Ability to work successfully in a fast-paced team-oriented environment, with the ability to also work independently with minimal supervision. • Strong attention to detail and excellent writing skills. • Must have strong written and verbal communication and organizational skills. • Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook). • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations. • Ability to stand/sit/walk for long periods of time.