Regulatory Writer I

Role Description

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.

What You’ll Do

• Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of general correspondence, INDs, CTAs, protocol and information amendments, annual reports, Safety reports, meeting briefing documents, PSPs, and NDAs/MAAs, as well as peer-reviewed manuscripts, slide decks, and posters with oversight and assistance as needed.
• 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.

Qualifications

• 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.

Requirements

• 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, research, and investigative skills.
• Ability to work in an ever-changing environment; demonstrated ability to multitask and achieve deadlines and targets under time constraints.
• Strong time management skills, with the ability to work on multiple projects simultaneously.
• Ability to work well in a team environment, with the ability to work effectively independently.
• Multi-lingual communication is a plus.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Competitive salaries along with a 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Offering peace of mind to help you and your family feel secure.
• We'll reimburse you to support your remote workspace and wellness purchases.
• No matter what issues you're facing, New Directions is here to help you and your family.
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.