Manager, Medical Writer and Quality Control

Scorpion Therapeutics; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a Manager, Medical Writer and Quality Control to support regulatory documentation for cell and gene therapy programs. You will produce high-quality clinical and regulatory documents aligned with US, EU, and ICH standards to enable global filings.

Remote role based in Philadelphia, PA, with no travel specified. You will author and review INDs/DMFs, manage timelines, and mentor team members in regulatory writing and quality control processes.

Qualifications

• Requires biological sciences degree(s) and strong writing ability.
• Experience with regulatory requirements for biologics/pharmaceuticals and global filings is essential.
• Must have excellent analytical, writing, and communication skills.

Responsibilities

• Author and review clinical protocols, investigator brochures, informed consents, and regulatory submissions (INDs, IMPDs, etc.).
• Manage document timelines, ensure finalization and publication readiness, and train team members in technical writing.

Skills

Technical Writing

Regulatory knowledge

US/EU/ICH standards

MS Office

Adobe Pro

Communication skills

GxP knowledge

Education

Bachelor's or Master's in Biological Sciences

Ph.D. in Biological Sciences

Tools

Adobe Acrobat Pro

MS Office Suite

Job description

Role

Manager, Medical Writer and Quality Control supporting regulatory documentation for cell and gene therapy programs in autoimmune diseases. Primary objectives include producing high-quality clinical and regulatory documents aligned with US, EU, and ICH standards to facilitate global filings.

Responsibilities

• authoring and reviewing clinical protocols, investigator brochures, informed consents, and regulatory submissions such as INDs, IMPDs, and other dossiers; managing document timelines; ensuring finalization and publication readiness; collaborating with clinical operations and CROs; and training team members in technical writing.

Qualifications

• Bachelor's or Master's in biological sciences with 6+ years experience, or Ph.D. with 2+ years experience in technical writing; familiarity with regulatory requirements for biologics/pharmaceuticals; experience with global regulatory filings; strong analytical, writing, and communication skills; proficiency in MS Office and Adobe Pro.

Preferred

• biotech or startup industry experience, prior regulatory submission review experience.

High-Value

• focus on cell/gene therapies targeting autoimmune diseases, involved in clinical development stages, supporting global regulatory filings, ensuring compliance with GxP and ICH standards.

Work Setup

Remote, based in Philadelphia, PA, with no specific travel noted.