Senior Documentation Control Specialist

Location: On-Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL locations

About Summit:

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• 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.

Colorectal Cancer (CRC)

• 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 Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

Overview of Role:

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

Role and Responsibilities:

• Support Quality team managing the electronic quality management documentation management system including uploading and archiving documents and handling associated requests
• Delivers 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 in an effective manner. Also ensures ongoing development and enhancement of the toolset to meet evolving business requirements.
• Checks / maintains the compliance and quality of the documents in relation to Standard(s) Guidance and Summits procedures and expectations
• Responds to documentation enquiries giving appropriate access to information
• Supports other functions in drafting reviewing and approving documents / records using the QMS
• Supports the ongoing maintenance and improvement of standard operating procedures and user guides
• Reports on progress of documents ensuring that documents are reviewed and approved within the review cycle
• Supports in any other tasks as deemed appropriate by the Line Manager.
• Support with QC checks for Regulatory and Safety team.

Experience Education and Specialized Knowledge and Skills:

• Minimum of 5 years of experience in a biotech or pharma industry.
• Bachelors degree in science/life science related field and/or pharmaceutical sciences.
• Must have excellent verbal and written communication skills.
• Must be 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.
• Understands pertinent regulations for the industry for example 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 $97000-$114000 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.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.