Senior Documentation Control Specialist

Location

On‑Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s Team Is Inspired To Touch And Help Change Lives Through Summit’s Clinical Studies In The Field Of Oncology. Summit Has Multiple Global Phase 3 Clinical Studies, Including:

• HARMONi:
  Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi‑3:
  Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first‑line metastatic NSCLC.
• HARMONi‑7:
  Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first‑line metastatic NSCLC.

• HARMONi‑GI3:
  Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Reporting to the Director, Quality Systems, the Documentation Support Specialist will be supporting GxP operations  role encompasses a range of duties including the following:

• Support Quality team managing the electronic quality management documentation system, including uploading and archiving documents and handling associated requests.
• Deliver the ‘Service Owner’ role for the electronic Quality Management System to ensure the system is used by the wider organization and any error reporting is handled effectively. Also ensures ongoing development and enhancement of the toolset to meet evolving business requirements.
• Check and maintain the compliance and quality of the documents, in relation to Standard(s), Guidance and Summit’s procedures and expectations.
• Respond to documentation enquiries, giving appropriate access to information.
• Support other functions in drafting, reviewing and approving documents/records using the QMS.
• Support the ongoing maintenance and improvement of standard operating procedures and user guides.
• Report on progress of documents, ensuring that documents are reviewed and approved within the review cycle.
• Support in any other tasks as deemed appropriate by the Line Manager.
• Support with QC checks for Regulatory and Safety team.

• Minimum of 5 years of experience in a biotech or pharma industry.
• Bachelor’s degree in science/life science related field and/or pharmaceutical sciences.
• Excellent verbal and written communication skills.
• Highly organized with a strong attention to detail.
• Intermediate to advanced skills in MS Office Suite (Outlook, Excel, Word, PowerPoint).
• Ability to work with minimal guidance; proactive, motivated self‑starter.
• Understanding of pertinent regulations for the industry, e.g., GLP, GCP, and 21 CFR Part 210, 211, and 820, ICH Guidelines, etc.
• Minimum of two years in Quality Assurance in the Pharmaceutical/Biotechnology industry.
• Experience in maintaining GXP training records, materials, or courses.

The pay range for this role is $97,000–$114,000 annually. 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, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.