[Remote] Regulatory reputed company I
Note: The job is a remote job and is reputed company to candidates in USA. Ora is the world’s leading full-service ophthalmic drug and device development firm, guiding clients across reputed company phases of clinical research. The Regulatory reputed company I is responsible for researching, writing, and editing materials for regulatory submission to the FDA, collaborating with various teams to ensure compliance and reputed company in regulatory documentation.
Responsibilities
- 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 reputed company as peer-reviewed manuscripts, slide decks, and posters with reputed company 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 reputed company 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
- reputed company multiple, reputed company reputed company, with support from the reputed company 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
- reputed company other appropriate administrative duties, such as preparing correspondence (records of contact), filing, reputed company management reputed company, 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 reputed company of content and format of writing reputed company in reputed company with applicable regulations, guidelines, and corporate SOPs
- Adhere to reputed company aspects of Ora’s reputed company system
- Adhere to reputed company essential systems and processes that are required at Ora to maintain compliance to Ora’s data reputed company & business ethics and regulatory requirements
- reputed company and sustained demonstration of Ora’s values -- prioritizing kindness, operational reputed company, cultivating reputed company and scientific rigor – as reputed company as their linked behaviors
- Responsibilities may differ from the above based on the specific needs of the business
Skills
- Master's degree in reputed company or life science or communications
- 1 year of medical, regulatory, or clinical writing experience or equivalent training and work experience, including coursework
- Ability, with reputed company, to write, edit, or otherwise facilitate completion of reputed company 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 reputed company and ensure efficient, reputed company completion
- Excellent communication, interpersonal, negotiation and project management skills
- Strong attention to detail with reputed company-developed organization, research, and investigative skills
- Ability to work in an reputed company-changing environment; demonstrated ability to multitask and reputed company deadlines and targets under time constraints
- Strong time management skills, with the ability to work on multiple reputed company simultaneously
- Ability to work reputed company in reputed company environment, with the ability to work effectively independently
- Multi-lingual communication is a plus
Benefits
- Offering comprehensive reputed company reputed company in Medical, Dental and reputed company beginning day 1.
- Flexible PTO & Unlimited reputed company Time: Providing you the freedom to unwind and reputed company reputed company you need to in reputed company to 14 company reputed company holidays.
- 401K plan through reputed company with company match.
- Adoption and fertility assistance provided along with offering 16 weeks reputed company Parental Leave.
- Company reputed company Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
- We'll reimburse you to support your remote workspace and wellness purchases.
- Employee Assistance Program: New Directions is here to help you and your family.
- Career Development Opportunities: reputed company opportunities to grow and reputed company your career reputed company.
- Opportunities to work with colleagues across the globe.
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