Scientist II NSRM
Scientist II NSRM
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Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
Nonclinical strategy and report management (NSRM) is a crossfunctional group supporting nonclinical regulatory submissions and preparation of nonclinical documents. NSRM works with nonclinical research nonclinical safety immunology regulatory QC/QA and research operations groups to produce scientifically accurate and compliant documents including but not limited to SOPs manuscripts protocols study reports investigator brochures IND and BLA modules.The nonclinical strategy and report management Scientist will primarily support the progression of a nonclinical program from research phase to development. This involves aiding in the compilation of nonclinical reports for an Investigational New Drug (IND) application. The nonclinical strategy and report management Scientist will be responsible for nonclinical data quality in reports submitted for regulatory filings literature searches and reference checks and drafting of study reports. The scientist will also be responsible for assisting in data interpretation and figure generation for reporting and may assist in statistical analysis of final data sets. Additional responsibilities include storyboard preparation and risk mitigation through collaborative problem solving. The position may shadow and potentially assist with inlab activities on a limited basis to effectively perform their role. In collaboration with reporting leads the nonclinical strategy and report management Scientist will be responsible for the management of study reports that will be used for internal purposes as well as for regulatory submissions.
The Opportunity to Make a Difference
- Aids in preparation of complex nonclinical and regulatory documents to support IND submissions including but not limited to protocols study reports amendments investigator brochures eCTD formatting eCTD table and figure formatting and IND/IMPD sections.
- Reviews experimental results and interpretation of nonclinical data
- Scientific contributor and subject matter expert who interprets data and applies knowledge of regulatory and scientific requirements to support document preparation
- Effectively collaborates with crossfunctional teams to produce clearly written highquality and scientifically accurate documents and ensure consistency between related documents
- High competency in writing editing and reviewing nonclinical and regulatory documents per company and other guidelines
- Ensures accuracy of data reported in documents being filed with regulatory agencies
- Performs and/or assists with quality control peer reviews of nonclinical documents
- Identifies opportunities to improve operational efficiency and compliance and assesses regulatory guidelines for impact to nonclinical studies.
- Demonstrated critical thinking and creative problemsolving skills across a range of scientific disciplines including a constant grounding in analyses
More about You
- PhD with experience in cellular or molecular biology or related discipline
- Excellent writing presentation and project management skills
- Meticulous attention to detail and ability to comply with company style guides and templates
- Ability to create strong collaborative working relationships operating as part of a team
- Proficient in Graphpad Prism RStudio/Python Microsoft Excel and Microsoft Word
- Competent applying common statistical tests for data analysis
- Excited to implement knowledge of FDA/international regulations ICH guidelines and applicable regulatory processes related to document preparation and production
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Employment Type
Full-Time
