Regulatory Writer I

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. 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. 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. 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, 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 • Competencies and Personal Traits: • What We Do: • • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. • How We Do It: • • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. • Why We Do It: • • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see. What We Offer: • Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1. • Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. • Financial: Competitive salaries along with a 401K plan through Fidelity with company match. • Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. • Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. • Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. • Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. • Career Development Opportunities: Continued opportunities to grow and develop your career journey. • Global Team: Opportunities to work with colleagues across the globe. • Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Our Privacy Policy | Ora (oraclinical.com)