Regulatory Writer I

About the role

Our Regulatory Writer I is responsible for researching, writing, and editing materials for regulatory submission to the FDA from pre-clinical to clinical trials Phase 1 - 4. This is an individual contributor working on a team as an active partner in regulatory project planning and execution reporting to the Manager of Regulatory. Ora's Regulatory Writer I will work collaboratively with our Clinical Project Managers, Clinical Trial Associates (CTA) and cross-functional departments such as Clinical Operations, Quality Assurance, Operations and Chemical Manufacturing Control (CMC). The Regulatory Writer I will identify and execute the timeline plans for clinical, nonclinical, and CMC by way of coordinating, authoring, and developing domestic and international drug applications and submissions in support of clinical programs within the US and globally. This role offers high visibility and exposure to working with the FDA regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, and/or eCTD format.

Responsibilities

• Assist in the research of scientific and regulatory information in order to write submission documents.
• Work with data management and clinical teams, as well as sponsors and KOLs to review protocol development and interpret clinical trial data for CSRs
• Responsible for contributing to the development of project timelines and the planning of regulatory milestones and tracking of commitments.
• Responsible for communication of commitments to team members.
• Lead multiple, concurrent projects, with support from the Principal or Regulatory Manager
• Format and edit regulatory documentation for inclusion in INDs, CTAs, and other global submissions.
• Support on-time preparation and publication of regulatory submission documents in coordination with the Regulatory Operations function
• Perform other appropriate administrative duties, such as preparing correspondence (records of contact), filing, quality management system support, where necessary.
• Maintain chronological and operational trackers as needed.
• Assist other writers in the compilation, writing, and editing of regulatory, scientific manuscript, marketing deliverables, and trade journal articles.
• Ensure quality of content and format of writing projects in accord with applicable regulations, guidelines, and corporate SOPs
• 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.
• Responsibilities may differ from the above based on the specific needs of the business.
• What We Look For:
• Experience needed for the Role:
• Master's degree in applied or life science or communications
• 1 year of medical, regulatory, or clinical writing experience or equivalent training and work experience, including coursework.
• Additional Skills & Attributes:
• Ability, with oversight, to write, edit, or otherwise facilitate completion of all clinical regulatory document types, including eCTD documents or similar, or protocols for Early Phase, Phase II or Phase III trials
• Ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams.
• Goal-oriented with an ability to set detailed timelines for completion of assigned projects and ensure efficient, timely completion
• Excellent communication, interpersonal, negotiation and project management skills
• Strong attention to detail with well-developed organization, res

Additional Information

POSITION TITLE: Regulatory Writer I DEPARTMENT: Regulatory Ora Values the Daily Practice of... Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.

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