Quality Control Specialist, Medical Writing
New
J
JobgetherMedical Writing
Fully remote work arrangement within the United States.Full-TimeMiddle
Salary$74,600–$99,600 annually
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Job Details
- Languages
- English
- Experience
- At least 1 year of relevant industry experience as a QC editor or specialist, medical writer, technical copyeditor, or in a comparable role.
- Required Skills
- SharePointMicrosoft Office
Requirements
- Bachelor’s degree required; a Master’s, PhD, PharmD, or other graduate-level degree is a plus.
- At least 1 year of relevant industry experience as a QC editor or specialist, medical writer, technical copyeditor, or in a comparable role.
- Demonstrated experience conducting QC reviews of pharmaceutical regulatory documents, particularly clinical study reports, protocols, or protocol amendments; experience with clinical sections of INDs, MAAs, and NDAs is an advantage.
- Strong written and verbal English communication skills, with the ability to communicate clearly, concisely, and effectively.
- Familiarity with the general drug and biologics development process and key regulatory submission requirements, including FDA regulations and ICH guidelines, is preferred.
- Strong attention to detail, particularly regarding scientific accuracy, grammar, syntax, formatting, consistency, and data integrity.
- Ability to manage multiple projects concurrently, prioritize effectively, meet tight deadlines, and maintain quality while responding to changing demands.
- Proficiency with Microsoft Word, Outlook, Excel, PowerPoint, and Adobe Acrobat, along with strong familiarity with Microsoft Windows.
- Familiarity with SharePoint and Veeva Vault is a plus.
Responsibilities
- Conduct quality control reviews of clinical and regulatory documents before final approval, ensuring they meet internal standards and applicable regulatory expectations.
- Perform cross-referencing, fact-checking, data verification, proofreading, and general quality assessments across documents such as clinical study reports, protocols and amendments, investigator’s brochures, INDs, NDAs, MAAs, manuscripts, abstracts, posters, briefing documents, health authority responses, narratives, and other medical writing deliverables.
- Review documents for grammar, syntax, formatting, consistency, hyperlink functionality, source data accuracy, and appropriate presentation and translation of data.
- Ensure documents follow established medical writing conventions, processes, templates, and applicable regulatory guidelines.
- Maintain a high level of attention to scientific accuracy and consistency across related documents while meeting demanding project timelines.
- Prioritize and manage multiple assignments simultaneously, adapting effectively to shifting priorities while maintaining high-quality output.
- Coordinate with medical writers and other stakeholders to maintain visibility into expectations, milestones, deliverables, and QC timelines.
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