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

Aroga Biosciences

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Manager, Scientific Writing