Sr. Technical Editor

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Writes, rewrites and/or edits technical/clinical documents such as clinical study protocols, clinical study reports, Investigator’s Brochures, and other regulatory submission documents to communicate clearly and effectively technical specifications and instructions to a wide range of audiences.

Job Description

• Edits technical/clinical documents such as clinical study protocols, clinical study reports, Investigator’s Brochures, and other regulatory submission documents.
• Prepare regulatory submissions to various health authorities in compliance with appropriate company business processes and external regulations/guidance/specifications.
• Submit eCTD submissions to health authorities and track related information in department databases.
• Publish (e.g. convert to PDF, bookmark, hyperlink) individual regulatory documents as needed.
• Remain current on internal/external electronic submission initiatives and requirements.
• Prepare and submit Periodic Adverse Drug Experience Reports in accordance with current FDA requirements.
• Identify and implement enhancements in business processes with other departments to ensure all eCTD submissions meet health authority requirements.
• Routinely assess the department’s electronic submission capabilities and processes and provide feedback to Regulatory management in order to improve efficiency.
• Perform checks on submission content plans to ensure the appropriate metadata is available to support the submission build.

Qualifications

• B.A. or B.S. degree and/or minimum 10 years’ technical or scientific writing or technical editing experience; pharma document production/publishing experienced preferred.
• Solid fundamental knowledge of drug discovery and development and regulatory processes and document types (e.g., NDAs, INDs, IBs, Annual Reports, official regulatory agency correspondence).
• Familiarity with Documentum or other electronic document management system is essential.
• Advanced knowledge of standard editing/proofreading conventions.
• Strong written and verbal communication skills.
• Detail-oriented and independent
• Ability to maintain composure and professional attitude while handling high-pressure deadlines is essential.

Commitment to Diversity, Equity, and Inclusion:  

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.