Manager, Document Management (Clinical and Regulatory)
Location: South San Francisco, California, United States
Supervise and maintain regulatory submission archival management systems and Trial Master Files (TMFs) ensuring they are current and inspection ready. Oversee all TMFs, monitoring for completeness, quality and timeliness across all relevant functional areas, as appropriate. Ensure document management systems and procedures are current and compliant with industry and regulatory standards. Responsibilities also include coordinating and assisting with regulatory submissions to global health authorities including document preparation, compilation and publishing activities.
Key responsibilities include:
Document management of Trial Master Files and regulatory submissions
- Facilitate and manage the production of inspection ready TMFs for ongoing and legacy studies to ensure accurate and timely TMF filing and maintenance according to International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines
- Manage/oversee internal eTMF and paper TMF set-up/systems, configuration, access permissions.
- Interact with Contract Research Organizations (CROs) to oversee TMF activities and develop oversight metrics and reviews, including review of CRO reports, audits, metrics, etc.
- Partner with study teams to conduct health checks of TMF for inspection readiness with the goal of compliance to regulations and global harmonization.
- Support teams and Quality Assurance during audits and health authority inspections with regards to TMF and eTMF.
- Provide eTMF/TMF training for staff.
- Oversee and interact with internal teams and CROs to ensure regulatory submission packages and health authority communications across all projects are filed, maintained and tracked in company document systems
- Provide support for preparation, review and QC of regulatory documents including completion of forms, document formatting and document control.
- Manage and coordinate compilation and publishing activities of regulatory submissions to global health authorities
- Assist with broader Clinical and Regulatory Operations efforts to implement and improve systems, processes, or tools.
Preferred Qualifications include:
- Bachelor’s degree with 8+ years, or master’s degree with 6+ years of relevant experience within a biopharmaceutical company, or contract research organization
- Experience with managing eTMF application(s) preferred but not mandatory
- Knowledge of the DIA Reference Model and how documents from various functional areas map and meet TMF filing requirements
- Knowledge of ICH, GCP and Good Documentation Practice (GDP) principles
- Experience with regulatory submissions (INDs, CTAs), regulatory document preparation, compilation and publishing
- Ability to engage in cross-functional interactions with internal and external staff
- Strong verbal and written communications skills, as well as problem-solving skills
- Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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