SUMMARY: The Senior Specialist, Regulatory Compliance is a global position responsible for performing quality review and approval of essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice prior to initiation of study sites. The Senior Specialist will assist in delivery of project timelines related to essential documents approval.

RESPONSIBILITIES:
Tasks may include but are not limited to:

• Assume the functional role of the global Regulatory Compliance Lead for assigned projects, providing project team representation for the division.
• Develop Essential Document Review Plan (EDRP), Essential Document Review Requirements (EDRF), customize country Essential Document (ED) checklists project ED templates for use by the site activation or clinical operations team, as applicable
• Provides instruction/training to sponsor/CRO personnel on policies and procedures related to essential document collection and maintenance.
• Oversee and ensure Essential Document package review and approval for the project is in accordance with the relevant Standard Operating Procedures, Working Instructions, EDRP and EDRF.
• Interfaces with the Site Activation Lead, Regulatory Affairs Lead, Site Contracts Lead and Global Project Lead, Sponsor as needed, to ensure appropriate prioritization of essential document review to facilitate synchronized study start up.
• Receive, review, process and file essential documents, part of the Essential Document package agreed for the project, in accordance with applicable local regulations, internal SOPs and guidelines and EDRP.
• Check the completeness of the Essential Documents packages as well as the quality of the documents provided
• Communicate corrective action and ensure issue resolution to meet documentation requirements as required, prior to approval of the Essential Document packages and ED checklist sign off.
• Complete/updated relevant tracking tool on ongoing basis to allow visibility to project teams on the Essential Document review progress status.
• Prepare and submits electronic copies of approved site essential documents, part of the Essential Document Package for filing in Trial Master File, as applicable.
• Work with a variety of Electronic Document Management Systems to review and approve Essential Documents, as needed.
• Escalate any quality issues in a timely manner to relevant parties.
• Perform additional tasks as assigned by their Line Manager

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Excellent organizational and time management skills
• Strong planning, monitoring scheduling and critiquing skills.
• Good interpersonal skills, with ability to clearly and concisely present information
• Ability to exercise sound judgment and ability to identify decisions requiring supervisory approval
• Excellent ability to handle multiple tasks in a fast -paced and constantly changing environment
• Proficiency in MS Office applications (Word, Excel, PowerPoint)
• Knowledge of ICH, GCP, FDA or EU directive regulations (as applicable) as well as local regulatory requirements
• Fluency in local language and working knowledge of English.

REQUIREMENTS:

• University degree preferred (Life Science desirable) and 3 years of relevant experience (1 year in similar role/position)or
• Combination of education and 4 years of similar role/position (2 years of similar role/position)

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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