Company Description
Aroga Biosciences is an award-winning Contract Research Organization (CRO) based in San Diego, CA, that specializes in providing 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. We prioritize delivering high-quality services while maintaining flexibility and compliance with regulatory standards.
Role Description
This is a full-time hybrid role for a Manager, Scientific Writing at Aroga Biosciences. The Manager will be responsible for overseeing scientific writing projects and writing teams. The role may involve the development of high-quality regulatory documents, such as study reports, M2 summaries (IND-level), early stage clinical protocols, and Investigator's Brochures. Grant writing and manuscripts may also be within scope. The position will require working collaboratively with cross-functional teams, reviewing and interpreting data, and ensuring compliance with regulatory guidelines and requirements. While the role is primarily based in San Diego, CA, there is flexibility for some remote work.
Qualifications
- Candidate should have a 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
- Those seeking this role should have management/mentorship experience
Benefits
- Competitive salary - salary and position commensurate with experience and background
- Comprehensive medical including Dental and Vision Insurance
- Flexible Work Week
- Hybrid work schedule – Onsite 1 day per week with the option to work remotely
- Remote employment may be considered with 10% travel
- 401K options
