Senior Publishing Specialist, Regulatory Affairs
Sr. Regulatory Affairs Publishing Specialist (Watertown, MA)
Job Locations
US-MA-Watertown
Job ID
2022-1285
Overview
See Your Future with EyePoint Pharmaceuticals
We are proud to be named a winner of the 2021 Deloitte Technology Fast 500 award, which recognizes the most innovative, fastest-growing companies in North America. We’re challenging the status quo in bio tech with a singular focus on vision-saving medications delivered through best-in-class proprietary pharmaceutical technologies and unique internal manufacturing capabilities to transform ocular drug delivery.
Our unique culture fosters a science-based entrepreneurial environment, with a collaborative, team-focused approach that embraces diversity, equity and inclusion. Our team’s wellbeing is paramount, which is why we offer comprehensive and highly competitive benefits.
For self-motivated leaders that are passionate about bio pharmaceuticals and ready to make a difference in the lives of patients, EyePoint Pharmaceuticals is a place you can be a catalyst for change and accelerate your career. If you share our vision for preventing blindness and have a passion for bio tech and disruptive change to improve patient care, review the requirements of this opportunity and apply today!
This role will provide support to the Regulatory Affairs department ensuring the delivery of timely and high-quality Regulatory submissions for all of EyePoint’s projects.
We are looking for a Senior Regulatory Affairs Operations Publishing Specialist to join our team at EyePoint Pharmaceuticals. This role will report to the Director, Regulatory Affairs, and will be based in Watertown, MA, offering a hybrid work schedule.
Responsibilities
Primary responsibilities include, but are not limited to, the following:
Individual responsibilities
- Assist in planning, preparation and submission of eCTD material through the FDA ESG
- Support Regulatory Operations and cross-functional teams in the planning, creation and tracking to completion of submission ready documents
- Review documents and edit their formatting and style to meet regulatory guidelines and compliance with departmental SOPs and style guidelines.
- Identify and prepare relevant FDA forms with submissions (e.g. 2253, 356h, 1571 etc)
- Update and maintain trackers for regulatory submissions, correspondence, health authority commitments to ensure all regulatory records are “audit ready”
- Organize and archive new and historic regulatory documents in Microsoft SharePoint and Veeva Vault Submissions Archive
- Contribute to the development and review of Standard Operation Procedures, Work Instructions, and guides relevant to Regulatory Operations
- Provide general administrative support such as updating trackers, taking meeting minutes, other special projects and miscellaneous duties as needed.
Qualifications
Primary skills and knowledge required include, but are not limited to the following:
- Strong knowledge of eCTD structure, ICH standards and submission requirements
- Experience with Publishing, Regulatory Writing and submission through the FDA ESG
- Proficient in the use of Microsoft Office, Adobe Acrobat Pro products and StartingPoint templates
- Excellent written and verbal communication skills including ability to write clearly and present information effectively
- Exceptional organizational skills, and the ability to think critically, independently and problem solve on tight deadlines
- Detail-oriented with the ability to understand the overall strategy of multiple projects/programs
Preferred:
- Experience with multiple cloud-based RIM systems (Veeva, Liquent, etc.)
- Some experience with ex-US submissions
- Experience with IND, NDA (including Ad Promo submissions) and CTA submissions
Level of Education Required:
- BA/BS with experience in the pharmaceutical industry or equivalent
Number of Years of Experience in the Function and in the Industry:
- 3+ years’ experience in Regulatory Operations/Affairs are required.
We are an ophthalmology focused company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders
EyePoint Company Values include:
- Success begins with our People – our employees are valued, relied upon and key to our company’s success
- Patient First – above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patients
- Integrity– we are always honest, open, ethical and fair
- Results-Driven– we are decisive and act with a sense of urgency against clear and aggressive goals
- Innovation – we strive for continuous improvement through thoughtful risk-taking
- Team Focus– we work and communicate in a collaborative, respectful and inclusive fashion
- Diversity & Inclusion - We commit to diversity in our staff and embrace inclusion and acceptance of others without bias
EyePoint Pharmaceuticals is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.