ora
Regulatory Writer I
Remote - US
Sponsorship not specifiedDetected 26 days ago
GCPProject ManagementNegotiationClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationTime ManagementGxP
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.
- 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).
- 1 year of medical, regulatory, or clinical writing experience or equivalent training and work experience, including coursework.
Responsibilities
- Assist in the research of scientific and regulatory information in order to write submission documents.
- Lead multiple, concurrent projects, with support from the Principal or Regulatory Manager
- 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.
- 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
Requirements
- Master's degree in applied or life science or communications
- 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.
Skills
- 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
Compensation
- 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.
Benefits
- 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.
- Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
- At Ora, we are creating vision beyond what we see.
Company info
- Regulatory Writer I
- 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.
- 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.
- Competitive salaries along with a 401K plan through Fidelity with company match.
- Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.
This listing is sourced directly from ora's careers page and normalized into a canonical job model.