... editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books 2. ...
... editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books 2. ...
... books, among others. Key Accountabilities: * Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety ...
... books, among others. Key Accountabilities: * Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety ...
Email Marketing Manager
OR · Remote
Strong writing and editing judgment, with the ability to evaluate copy, subject lines, CTAs, and ... Get up to 12 books reimbursed per year to fuel your learning. * Bucket List Benefit: Celebrate ...
Email Marketing Manager
OR · Remote
Strong writing and editing judgment, with the ability to evaluate copy, subject lines, CTAs, and ... Get up to 12 books reimbursed per year to fuel your learning. * Bucket List Benefit: Celebrate ...
Email Marketing Manager
OR · Remote
Strong writing and editing judgment, with the ability to evaluate copy, subject lines, CTAs, and ... Get up to 12 books reimbursed per year to fuel your learning. * Bucket List Benefit: Celebrate ...
Email Marketing Manager
OR · Remote
Strong writing and editing judgment, with the ability to evaluate copy, subject lines, CTAs, and ... Get up to 12 books reimbursed per year to fuel your learning. * Bucket List Benefit: Celebrate ...
Includes creating and editing Foundation correspondence templates; managing the disbursement of ... Maintain digital and hard copy Foundation Corporate books including minutes, bylaws and other ...
Includes creating and editing Foundation correspondence templates; managing the disbursement of ... Maintain digital and hard copy Foundation Corporate books including minutes, bylaws and other ...
Books Editor information
How do Books Editors typically collaborate with authors and other editorial staff throughout the publishing process?
Does JK Rowling use an editor?
What does a Books Editor do?
What are the key skills and qualifications needed to thrive as a Books Editor, and why are they important?
How much money do book editors make?
What is the difference between Books Editor vs Books Writer?
| Aspect | Books Editor | Books Writer |
|---|---|---|
| Required Credentials | Typically a bachelor's degree in English, Literature, or related field; editing experience | Usually a bachelor's degree in English, Literature, or creative writing; strong writing portfolio |
| Work Environment | Publishing houses, editing firms, freelance editing | Independent, publishing companies, freelance writing |
| Employer & Industry Usage | Used by publishers to refine manuscripts before publication | Used by publishers, authors, or freelancers to create original content |
| Common Search & Comparison Intent | Understanding editing roles, responsibilities, and skills | Understanding writing roles, skills, and career paths |
The main difference between a Books Editor and a Books Writer lies in their roles: editors focus on refining and improving manuscripts, ensuring clarity, consistency, and quality, while writers create original content from scratch. Both roles require strong language skills and relevant education, but their day-to-day tasks and career paths differ significantly.
Is there a high demand for book editors?
How can I get a job as a book editor?

Other
Posted 4 days ago
Job description
ultrafocused - Work together to fearlessly uncover new possibilities
The Associate Director, Medical Writing will be responsible for writing and coordinating the writing of various clinical and regulatory documents, including protocols/amendments, investigator brochures, clinical study reports, and NDA/BLA submission documents. The Associate Director, Medical Writing will work closely with cross-functional teams to manage the preparation of written clinical and regulatory documents, ensuring that they are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Associate Director will be seen as a key SME for medical writing, providing leadership across global teams.
Work Model:Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:1. Development and implementation of cross-functional input for clinical and regulatory documents including the drafting, editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books
2. Ensures smooth, effective, and timely document management from start (template) to finish (approval), which may include: first-draft authoring, literature and reference retrieval, editing, efficient comment resolution, and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) with high quality
3. Actively supports cross-functional project teams as the Clinical Regulatory Writing representative, providing input to ensure timely and accurate deliverables and negotiating timelines as necessary
4. Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.) and partners with Clinical Trial and Transparency colleges.
5. Develops effective collaborative relationships with other key functional stakeholders
6. Participates in department initiatives with other Clinical Regulatory Writing members to formulate writing strategies and standards to be implemented and takes responsibility for execution.
7. Distills large amounts of clinical and scientific data into essential elements for tabular and graphical display
8. Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance.
Requirements:1. BS, MS, or doctorate in a scientific or medical field
2. Six+ years in the biotechnology/pharmaceutical industry
3. Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus.
4. Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
5. Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
6. Proven ability to develop and implement medical writing processes and standards
7. Exceptional oral and written communication skills
8. Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
9. Flexible; adapts work style to meet organization needs
10. Strong organizational abilities and experience in a multitasking environment
11. Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
12. Dedication to quality and reliability
13. Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)
14. Ability to build and maintain effective partnerships, both internally and externally
15. Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels
16. Rare disease experience and/or gene therapy experience a plus
17. Ability and willingness to travel several times a year
#LI-CS1 #LI-Remote
About Ultragenyx
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Novato, CA, US
Year founded
2010