Job Title: Part-Time Contractor, Regulatory Operations

Location: Menlo Park, California (Remote)

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate clinical studies in the following NSCLC indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Overview of Role:

The Contractor, Regulatory Operations, is responsible for formatting and publishing electronic documents, ensuring submissions are of highest quality and timely delivered, and assisting with project oversight of complex submissions. This is a part-time contractor position.

Role and Responsibilities:

• Preparing high-quality electronic regulatory dossiers (eCTD) according to health authority requirements and guidance, including publishing and submission of dossiers
• Independently perform document formatting on MS Word documents, converting documents to PDF, and formatting PDFs to comply with FDA and other health authority specifications, including troubleshooting issues and identifying solutions.
• Performing quality control checks and working with the responsible person to address findings
• Identifying issues during document formatting and/or publishing and liaising with responsible person to resolve issues

Experience, Education and Specialized Knowledge and Skills:

• At least 3-5 years of industry experience, including preparation, publishing, and submissions for INDs, NDAs, and CTAs
• Bachelor's degree in life sciences or a related discipline required
• Strong expertise with document formatting on MS Word documents, converting documents to PDF, and formatting PDFs to comply with FDA and other health authority specifications
• Experience with project managing complex submissions
• Proficient knowledge of and experience with electronic publishing tools for regulatory submissions (experience with Lorenz docuBridge a strong plus)
• Proficient in using MS Office Suite (SharePoint, EndNote), Adobe Acrobat and ISIToolBox, StartingPoint templates, and other relevant tools
• Expert knowledge of eCTD submission requirements and lifecycle management of eCTD submissions
• Attention to detail, accuracy, and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Experience with document formatting (Word and PDF)
• Knowledge of applicable FDA, HC, EU, and ICH guidelines related to regulatory submissions, clinical trials, and marketing applications
• Strong computer and database skills

The pay range for this role is $50 to $60 per hour and will not exceed 20 hour per month. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, etc.

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