The TMF Contractor will provide specialized skills and expertise in support of our clinical trials and be responsible for overseeing and managing the Trial Master File for designated clinical trials, provide training to stakeholders, and be responsible for capturing key metrics and the presentation of such with stakeholders. Additionally, will provide TMF expertise during audit-readiness and audit day for designated studies.

　　RESPONSIBILITIES

　　Ensures the TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations

　　Manages document control processes and systems for GCP activities in compliance with regulatory requirements

　　Implements/Maintains TMF quality control processes aligned to company standards and within regulatory requirements

　　Organizes and provides TMF process implementation training to study teams ensuring compliance with SOPs, WIs and regulatory requirements

　　Coordinates TMF documentation collection, review, and submission with stakeholders

　　Manages and tracks TMF-related actions, issues, and risks and provides TMF-related guidance to stakeholders

　　Prepares and shares regular TMF metrics and status reports to study teams and CROs on the allocated studies

　　Conducts periodic TMF reviews ensuring GxP inspection readiness for Clinical Study in accordance with regulations.

　　Collaborates with inspection readiness teams and regulatory authorities on TMF-related inquiries and inspections.

　　Supports company management with successful eTMF systems global implementation.

　　Participates in process improvement efforts by identifying and reporting gaps in processes to company management.

　　Other duties as assigned

　　MINIMUM JOB REQUIREMENTS

　　Bachelor's degree or equivalent education in life sciences, record management, public health management, or related fields

　　5 years relevant experience within the pharmaceutical or biopharmaceutical industry

　　Knowledge of international and local regulatory requirements for clinical trials and guidelines, such as ICH-GCP and FDA/EMA/PMDA regulations

　　Understanding of clinical trial processes, including study design, patient recruitment, data management, and reporting

　　Experience with electronic TMF systems and technologies, preferably Veeva Vault and with other technologies such as MS Office applications and databases

　　Experience in managing multiple projects and coordinating with cross-functional teams

　　Ability to prioritize, manage, organize, and maintain large amounts of documentation, both electronic and paper

　　Effective communication and interpersonal skills

　　Ability to learn new concepts with reasonable ease and train others on new concepts in a manner that is easily understood and comprehended

　　High attention to detail to ensure that all required documentation is accurate, complete, and compliant

　　Ability to identify and manage risks and resolve issues in a timely manner

　　Skilled at problem-solving and proposing solutions

　　ESSENTIAL PHYSICAL REQUIREMENTS

　　Ability to articulate clearly and conduct verbal presentations with large and small audiences.

　　Ability to travel via automobile and/or airplane.

　　Ability to view video display terminal images 18 away from face for extended period of time up to four (4) hours at a time.

　　Ability to operate a computer keyboard and telephone.

　　Ability to sit for extended periods of time up to four (4) hours at a time.

　　Ability to lift, tug, pull up to fifteen (15) pounds.

　　To be considered for this position, you must apply and meet the requirements of this opportunity.

　　We look forward to reviewing your resume & qualifications.

　　DISCLAIMER

　　The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilitiesmay change or be assigned at any time with or without notice.

　　EEO

　　Shionogi Inc. is an equal opportunity/affirmative action employer.

　　All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

　　It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

　　Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

　　The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity