Associate II, Nonclinical Strategy And Report Management

Nonclinical strategy and report management (NSRM) is a cross-functional group supporting preparation of nonclinical documents. NSRM works with the nonclinical safety, immunology, nonclinical research, 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 Associate II 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 Associate II will be responsible for the organization and review of raw data forms, data transcription from raw data forms to excel, prism or other data files, assembly and QC of data tables, literature searches and reference checks, and formatting of study reports. In order to effectively, write SOPs, QC and review data, the position will shadow, and potentially assist with in-lab activities including but not limited to western blot, ddPCR, protein isolation, DNA and RNA isolation, tissue sectioning, and immunological assays. In collaboration with scientists in the nonclinical strategy and report management, the nonclinical strategy and report management Associate II will produce portions of study reports that will be used for internal purposes as well as for regulatory submissions.

Primary Responsibilities Include:

• 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.

• Contributes to the coordination of cross-functional teams to produce clearly written, high-quality, and scientifically accurate documents and ensure consistency between related documents

• Performs and/or assists with quality control peer reviews of nonclinical documents

• Performs and/or assists with data transcription for generation of regulatory reports

• Contribute the peer review of nonclinical data packets included in regulatory filings

• Responsible for study closure activities, including preparation of nonclinical documents for archiving

• Ensure compliance with GCP/GLP guidelines.

• Perform other related duties as assigned.

Desired Education and Skills:

• M.A./M.S. Degree with 0-2 years related experience

• background in writing nonclinical documents preferred

• Understanding of FDA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production, including a solid understanding of CTD structure and content

• Excellent organization and communication skills and ability to collaborate effectively

• Demonstrates great attention to detail

• Desire to work in a dynamic, fast-paced team environment

• Self-motivated individual with a strong work ethic

• Proficient in Graphpad Prism, Microsoft Word, Excel, and PowerPoint

#LI-Onsite

This position requires work on site at one of Sarepta's facilities in the United States.

The targeted salary range for this position is $68,400 - $85,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.