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Ora · 1 month ago

Senior Regulatory Operations Specialist

United States

Full-time

Remote

Senior Level

5+ years exp

Ora is the world’s leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research. The Senior Regulatory Operations Specialist will assist the Regulatory submissions team in quality control, document preparation, and submissions primarily within Europe.

BiotechnologyConsultingHealth CareLegalPharmaceutical

Responsibilities

Performs the role of a Regulatory Lead for studies within the European region during study start-up until study close out

Oversees and performs quality control checks on clinical and regulatory documents

Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS)

Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora’s submission standards

Prepares Master Patient Information Sheet (PIS)/Informed Consent Form (ICF) with supervision

Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalization

Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms

Performs data entry for tracking of regulatory submission documents and activities

Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents and regulatory approvals are filed in collaborative workspace

Prepares the clinical trial application within CTIS with supervision; in compliance with forecasted timelines

Escalates potential issues identified to impact forecasted timelines quickly

Prepare and deliver training to internal team

Provide SME guidance and support to internal operational team and external clients

Provide oversight and guidance to more junior team members

May be required to provide regulatory support in other regions

Keep up to date with current regulations, guidelines and changes in the industry

Collaboration with Global Regulatory team and wider stakeholders

Adhere to all aspects of Ora’s quality system

Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements

Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors

Qualification

Regulatory submissionsClinical Trial Information System (CTIS)Clinical research experienceMicrosoft OfficeAttention to detailMulti-lingual communicationTeam collaborationVerbal communicationWritten communicationProblem-solving

Required

Bachelor's degree in applied or life science/healthcare or equivalent

5 years of regulatory, or clinical experience or equivalent training and work experience, including coursework

Experience with clinical research including overseeing or making submission in a country or region

Experience with Clinical Trial Information System (CTIS) and EU CTR

Competency in Microsoft Office applications, especially Word

Ability to work well in a team environment, have a strong commitment to the accomplishment of tasks, can follow procedures, and has the initiative to identify opportunities for improvements and the inter-personal skills to promote and accomplish constructive solutions to problems

Ability to work in a fast-paced environment

Attention to detail with emphasis on accuracy and quality

Ability to prioritize work to balance multiple projects and deadlines

Excellent verbal and written communication skills

Experience generating and adapting PIS/ICF templates

Familiarity with the clinical trial process and regulatory submissions regulations and guidelines within the EU

Familiarity with ICH-GCP standards