Regulatory Writer I

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🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

✏️ Content Writer

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Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, we have proudly helped our clients earn more than 85 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. 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. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Responsible for researching, writing, and editing materials for regulatory submission to the FDA from pre-clinical to clinical trials Phase 1 - 4 • Works collaboratively with Clinical Project Managers, Clinical Trial Associates (CTA) and other cross-functional departments • Identifies and executes timeline plans for clinical, nonclinical, and CMC • Coordinates, authors, and develops drug applications and submissions in support of clinical programs • Offers high visibility and exposure to FDA regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, and/or eCTD format • Author and compile FDA and Ex-US regulatory applications and submissions • Assist in the research of scientific and regulatory information to write submission documents • Work with data management and clinical teams to review protocol development and interpret clinical trial data • Responsible for contributing to project timelines and regulatory milestones • 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

🎯 Requirements

• 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 • 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

• Health insurance • 401K plan with company match • Flexible PTO • Unlimited sick time • 14 company paid holidays • Adoption and fertility assistance • 16 weeks paid parental leave • Company paid life and disability insurance • Remote workspace and wellness reimbursement • Employee assistance program • Career development opportunities • Opportunities to work with colleagues across the globe • Chance to research new ophthalmic therapies