Quality Control Specialist, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and finalize assigned quality-control evaluations of clinical and regulatory documents.

• Conduct copyediting, proofreading, cross-referencing, fact-checking, data validation, and overall quality assessments.

• Examine study reports, clinical study protocols and amendments, investigator’s brochures, INDs, NDAs, MAAs, manuscripts, abstracts, posters, briefing documents, responses from health authorities, and narratives.

• Ensure that documents comply with internal standards, Global Medical Writing conventions, relevant regulatory guidelines, and project timelines.

• Maintain consistency across related documents and verify hyperlinks, data sources, formatting, grammar, syntax, and scientific accuracy.

• Manage multiple projects and execute QC reviews under tight deadlines and changing priorities.

• Liaise with Medical Writers regarding expectations, milestones, and deliverables.

• Contribute to team direction and strategic discussions.

• Foster partnerships with teams across departments.

• Engage in training related to medical writing, medical terminology, drug and biologics development, and various document types.

⛳️ Requirements

• Excellent English communication skills, both written and verbal, that are clear, concise, and effective.

• Experience in conducting medical writing quality-control reviews of regulatory documents within the pharmaceutical industry or technical editing in a related field.

• Preferred familiarity with the drug and biologics development process and regulatory submission requirements as per FDA regulations and ICH guidelines.

• Technical proficiency in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat.

• Competence in navigating Microsoft Windows.

• Familiarity with SharePoint and Veeva Vault is an advantage.

• Bachelor’s degree (BA/BS) required.

• A minimum of 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Participation in an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Opportunity to voluntarily participate in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Flexibility to work remotely or from any of BeOne’s global offices.