Scientific Writing Manager
1 week ago
About Aroga Biosciences
Aroga Biosciences is a leading Contract Research Organization (CRO) specializing in regulatory writing and submission services for biotech and pharmaceutical projects. Our team comprises experienced scientists with extensive regulatory and medical writing expertise across various therapeutic areas.
Role Overview
This is a full-time hybrid role for a Scientific Writing Manager at Aroga Biosciences. The Manager will oversee scientific writing projects and writing teams, ensuring high-quality regulatory documents are developed in compliance with regulatory guidelines and requirements.
Key Responsibilities
- Develop and manage scientific writing projects, including study reports, M2 summaries, early stage clinical protocols, and Investigator's Brochures
- Collaborate with cross-functional teams to review and interpret data, ensuring compliance with regulatory standards
- Lead writing teams to produce high-quality regulatory documents
- Develop and maintain knowledge of regulatory guidelines and requirements
- Provide guidance and mentorship to junior team members
Requirements
- M.S., Ph.D., Pharm.D, M.D., or equivalent degree
- Scientific Writing, Medical Communications, and/or Medical Writing skills
- Experience in writing and reviewing regulatory documents, particularly IND experience
- Strong research and analytical skills
- Excellent written and verbal communication skills
- Attention to detail and ability to meet tight deadlines
- Knowledge of regulatory guidelines and requirements
- Experience in the biotech or pharmaceutical industry is a plus
What We Offer
- Competitive salary and benefits package
- Comprehensive medical, dental, and vision insurance
- Flexible work schedule with hybrid work arrangement
- Remote employment options with occasional travel
- 401K options
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