Aroga Biosciences
Director, Medical Writing and Submissions
Aroga Biosciences, San Diego, California, United States, 92189
Director, Medical Writing and Submissions
Overview
This is a full-time hybrid role located in the San Diego Metropolitan Area for a Director, Medical Writing and Submissions. The Director will oversee and coordinate the medical writing and submission activities, ensuring adherence to regulatory standards. Responsibilities include managing medical writers, collaborating with cross-functional project teams, developing regulatory documents, and ensuring all deliverables meet quality and compliance requirements. Company Description
Aroga Biosciences is an award-winning CRO known for its highly experienced regulatory writing and submission services for biotech and pharmaceutical projects. Our team consists of scientists with extensive expertise in regulatory and medical writing across a broad range of therapeutic areas. We are dedicated to delivering high-quality deliverables while maintaining flexibility and strict adherence to regulatory standards. Responsibilities
Oversee and coordinate medical writing and submission activities, ensuring adherence to regulatory standards. Manage medical writers and collaborate with cross-functional project teams. Develop regulatory documents and ensure all deliverables meet quality and compliance requirements. Qualifications
Extensive knowledge in the life sciences (M.S., Ph.D., Pharm.D., M.D./D.O. preferred) 3 years’ experience working in the biopharma industry Strong leadership and team management skills Excellent written and verbal communication skills Ability to manage multiple projects and meet deadlines Hybrid work schedule – Onsite at least 1 day/week with the option to work remotely other days Remote employment may be considered with 10% travel 401K options Flexible Work Week Salary Range:
$150,000 – $175,000 annually. This range reflects the base salary the employer reasonably expects to pay for this position in California. Actual compensation within the range will be determined based on relevant factors such as experience, skills, qualifications and geographic location. Employment type
Full-time Job function
Health Care Provider
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Overview
This is a full-time hybrid role located in the San Diego Metropolitan Area for a Director, Medical Writing and Submissions. The Director will oversee and coordinate the medical writing and submission activities, ensuring adherence to regulatory standards. Responsibilities include managing medical writers, collaborating with cross-functional project teams, developing regulatory documents, and ensuring all deliverables meet quality and compliance requirements. Company Description
Aroga Biosciences is an award-winning CRO known for its highly experienced regulatory writing and submission services for biotech and pharmaceutical projects. Our team consists of scientists with extensive expertise in regulatory and medical writing across a broad range of therapeutic areas. We are dedicated to delivering high-quality deliverables while maintaining flexibility and strict adherence to regulatory standards. Responsibilities
Oversee and coordinate medical writing and submission activities, ensuring adherence to regulatory standards. Manage medical writers and collaborate with cross-functional project teams. Develop regulatory documents and ensure all deliverables meet quality and compliance requirements. Qualifications
Extensive knowledge in the life sciences (M.S., Ph.D., Pharm.D., M.D./D.O. preferred) 3 years’ experience working in the biopharma industry Strong leadership and team management skills Excellent written and verbal communication skills Ability to manage multiple projects and meet deadlines Hybrid work schedule – Onsite at least 1 day/week with the option to work remotely other days Remote employment may be considered with 10% travel 401K options Flexible Work Week Salary Range:
$150,000 – $175,000 annually. This range reflects the base salary the employer reasonably expects to pay for this position in California. Actual compensation within the range will be determined based on relevant factors such as experience, skills, qualifications and geographic location. Employment type
Full-time Job function
Health Care Provider
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