
Content Development Specialist
2 days ago
This role is responsible for editing documents according to client and industry specifications, templates, style guides, and other relevant documents while considering business objectives, project deliverables, timelines, and quality expectations.
">Responsibilities- Document Quality Review and Control
Demonstrate expertise in all aspects of quality control review, including document verification against source material, internal consistency, grammar accuracy based on understanding of grammar rules, and training others in this knowledge. - Formatting and Publishing Expertise
Perform formatting techniques consistently with company guidelines, including template utilization, style application, table insertion, figure creation, overall document appearance, and function (e.g., Table of Contents and cross-references), and resolve document quality issues. - Publishing Documents and Leadership
Publish documents to regulatory health standards, learn requirements for submission-ready documents, and the submission structure. Demonstrate effective leadership for all document quality-related tasks and services, including leading projects, coordinating with team members, managing timelines and budgets, communicating client feedback, providing strategic insight, and proposing ways to improve performance. - Communication and Collaboration
Communicate clearly and effectively in written and verbal form, align daily actions with applicable standard operating procedures, work instructions, and Technical Editor best practices, and remain in compliance with training and position standards. - Mentorship and Performance Management
Meet quality expectations and deliverables in daily performance, align daily activities with business and personal productivity goals, respond positively to feedback, adjust performance accordingly, and proactively communicate opportunities for growth and learning to management. Mentor more junior staff to become proficient in quality control review, formatting, and/or publishing tasks.
- Bachelor's degree in English, journalism, scientific discipline, or related field with an interest in regulatory writing.
- Editor in the Life Sciences certification desired, but not required.
- Strong computer skills, including proficiency with Microsoft Office Suite (e.g., Outlook, Word, Excel, PowerPoint) in terms of editing tools, creating and modifying tables, and inserting figures.
- At least 2 years of prior related experience; highly skilled, talented, and motivated candidates will be considered.
- Background in pharmaceuticals and/or science and technical industries preferred.
- Understanding of GXP, ICH E3, electronic Common Technical Document (eCTD), AMA style guidance, and version control, and MS Word template.
- Proven success in team-based environment.
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