Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.

Primary Responsibilities:

Document the processes involved in building RWD, including data collection, integration from various sources, and quality assurance Develop and maintain comprehensive documentation for data validation and quality control protocols Extract and compile relevant information from physician notes and other unstructured data sources Write detailed reports and dossiers for clinical trial submissions to regulatory bodies such as the FDA Collaborate with cross-functional teams to ensure accurate and comprehensive documentation of RWD methodologies Prepare scientific manuscripts, abstracts, posters, and presentations for peer-reviewed journals and conferences Stay updated with the latest advancements and methodologies in RWD, clinical trials, and commercial analytics Ensure compliance with all regulatory requirements and industry standards for documentation and reporting Contribute to the development of best practices for RWD documentation and utilization in clinical and commercial settings Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so

Required Qualifications:

Ph.D. in Pharmaceutical Sciences, MBBS/MD, Clinical Research, or a related field 1+ years of experience in medical writing, particularly in the context of clinical trials and RWD Experience in writing dossiers for FDA submission Experience in extracting and documenting information from unstructured data sources such as physician notes Solid understanding of RWD methodologies and their applications in clinical trials and commercial analytics Proven excellent writing, editing, and communication skills Proven attention to detail and ability to work independently and as part of a team Proven solid organizational and project management skills Demonstrated ability to produce high-quality scientific publications in peer-reviewed journals

Preferred Qualifications:

Experience in a pharmaceutical or clinical research organization Experience in using data analytics tools and software Familiarity with regulatory requirements and guidelines for clinical trial documentation

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.