Manager, Medical Writing – Quality Control

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

📋 Description

• Assist in the creation and generation of clinical documentation, including protocols, investigator brochures, and informed consent forms.

• Prepare regulatory designations such as orphan drug applications, fast track designations, and RMAT applications for cell and gene therapy initiatives.

• Manage timelines for document preparation and communicate expectations, reviews, milestones, and deliverables effectively.

• Review and edit documents authored both internally and externally.

• Ensure that submission documents are ready for publication, quality-checked, finalized, and supported by comprehensive literature.

• Facilitate clinical trial readiness alongside clinical operations and CROs, including communications with IRB/IBC, study manuals, and related documentation.

• Maintain high quality and efficiency in technical documentation for regulatory filings.

• Transform technical study data and results into reports that support regulatory submissions.

• Train and mentor subject matter experts on technical writing skills and best practices.

• Participate in both internal and external project team meetings, offering proactive solutions and advice.

• Provide training on company document management systems and author or review clinical and regulatory SOPs.

• Perform other assigned tasks as needed.

⛳️ Requirements

• Bachelor’s or master’s degree in biological sciences with 6 years of experience in a technical writing role, or a Ph.D. with 2 years of experience.

• Knowledge of key requirements for regulatory submissions in ICH regions as well as applicable pharmaceutical and biologics regulations and guidelines.

• Preferred experience in reviewing and writing regulatory submission documents for global filings such as IMPDs, INDs, MAAs, NDAs, and BLAs.

• Ability to critically analyze, synthesize, and present complex information in well-structured documents.

• Working knowledge of drug and biologics development, clinical research, study design, biostatistics, regulatory environments, and medical terminology.

• Confidence in presenting to management, peers, and scientific or business collaborators.

• Ability to manage multiple projects and prioritize work independently.

• Ability to adhere to company and industry style guides and templates.

• Skill in guiding and training others in technical documentation writing.

• Proficiency in written and spoken English, with a keen attention to detail in consistency, grammar, syntax, and scientific accuracy.

• Advanced skills in Microsoft Word, Excel, and Adobe Pro.

• Preferred experience in the biotech industry or a startup industrial environment.

• Strong team orientation and a passion for ongoing self-development.

🏝️ Benefits

• Competitive benefits package.

• Paid Time Off (PTO).

• Stock option plans.

• Commitment to employee well-being and continuous growth.

• Opportunities for training and mentoring.