Medical Writing Operations Specialist II
Location: Global | Pharmaceutical & Biotechnology Sector
Job Type: Full-Time
Position Overview
We are seeking a Medical Writing Operations Specialist II to join our dynamic team. This role focuses on the quality review of regulatory documents to ensure accuracy, consistency, and compliance with global regulatory standards. Documents include clinical and nonclinical CTD Module 2 summaries, clinical study reports (CSRs), protocols, investigator brochures, briefing documents, and other cross-functional submissions supporting the drug development pipeline.
The ideal candidate will have experience in regulatory medical writing, a strong understanding of the drug development process, and the ability to deliver high-quality documents that meet company and regulatory standards.
Key Responsibilities
Review regulatory documents to ensure accuracy, consistency, and compliance with internal standards and global regulatory expectations.
Edit documents according to company style guidelines and American Medical Association (AMA) style.
Verify that complex documents are aligned with source data and internally consistent.
Track project timelines and communicate potential risks or delays to project managers or lead medical writers.
Support process improvements, authoring tools, and the creation or revision of internal policies and procedures.
Actively participate in cross-functional project teams and departmental meetings.
Other duties as assigned to support regulatory submissions and quality initiatives.
Education and Experience Requirements
Education:
Bachelor’s degree (BS/BA) in a related discipline with 5+ years of relevant experience, or
Master’s degree (MS/MA) in a related discipline with 3+ years of relevant experience, or
Equivalent combination of education and experience.
Preferred Certifications:
BELS (Board of Editors in the Life Sciences) certification is an advantage.
Professional Experience:
Minimum 3–5 years in pharmaceutical or biotechnology industries, with exposure to clinical development, quality assurance, or regulatory operations.
Experience reviewing regulatory submissions including INDs, NDAs, BLAs, sNDAs, TIIVs, CTDs, clinical protocols, and CSRs.
Knowledge of drug development processes, regulatory guidelines, and industry best practices.
Familiarity with VeevaRIM or other document management systems.
Experience in oncology or other therapeutic areas is preferred.
Core Competencies and Skills
Strong verbal and written communication with attention to detail.
Ability to manage timelines effectively and deliver high-quality outputs under tight deadlines.
Proficient in medical terminology and AMA style editing.
Ability to collaborate across matrixed, cross-functional teams.
Flexibility, initiative, and innovative problem-solving skills.
Strong organizational skills with a focus on quality and compliance.
Work Environment
Modern, open-plan office designed to encourage collaboration and creativity.
Equipped with ergonomic workstations and dual monitors for optimal productivity.
Supportive team environment fostering professional growth and knowledge sharing.
Compensation and Benefits
Competitive annual base salary: $102,000 – $144,000, adjusted by geographic location, experience, and internal equity.
Comprehensive benefits package including:
401(k) with company contributions
Medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program or sales-based incentive (if applicable)
Employee stock purchase and long-term incentive programs
15 vacation days in the first year, 17 paid holidays (including winter shutdown), and up to 10 sick days per year
Disclaimer
This job description provides a summary of the primary responsibilities and qualifications required for the role. It is not an exhaustive list of all duties and responsibilities, and additional tasks may be assigned as needed.
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