Senior Medical Writer

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

📋 Description

• Compose, revise, and structure clinical regulatory documents in accordance with both domestic and/or international regulatory submission standards and internal guidelines.

• Generate study reports, clinical study protocols and amendments, investigator brochures, as well as the clinical sections of INDs, NDAs, MAAs, and other regulatory submissions.

• Collaborate with cross-functional teams to create high-quality, scientifically precise documents within strict deadlines.

• Maintain consistency across related documents.

• Ensure that assigned documents undergo thorough quality checks prior to approval.

• Properly route documents during the review and approval processes.

• Manage timelines effectively and communicate expectations, milestones, and deliverables.

• Review and edit documents produced both internally and externally.

• Establish and sustain medical writing processes, standards, and tools.

• Ensure clinical documents comply with BeOne standards and regulatory requirements.

• Coordinate and oversee contract medical writers as necessary.

⛳️ Requirements

• A minimum of 4 years of relevant experience in the industry as a regulatory medical writer.

• Bachelor’s degree (BA/BS).

• Proven ability to communicate and write in English clearly, concisely, and effectively.

• Recent and substantial experience in writing regulatory documents, including clinical study reports, protocols, and protocol amendments.

• Strong understanding of FDA and ICH regulatory submission requirements.

• Experience in writing clinical sections of INDs, MAAs, and NDAs is advantageous.

• Preferred working knowledge of drug/biologics development, clinical research, study design, biostatistics, regulatory environment, and medical terminology.

• Capable of adhering to company and/or industry style guides and templates.

• Exceptional attention to detail regarding consistency, grammar, syntax, and scientific accuracy.

• Technical proficiency in Microsoft Word, Adobe Acrobat, and electronic document management systems.

• Proficiency in Microsoft Outlook, Excel, and PowerPoint.

• Ability to prioritize multiple projects and deliver high-quality documents under tight deadlines.

• Strong skills in project management and problem-solving.

• Capacity to work collaboratively and manage communications and reviews.

🏝️ Benefits

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

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

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

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.