Location: Watertown,MA, USA
Overview
Be Seen and Heard at EyePoint Pharmaceuticals
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for:
* preventing blindness through vision-saving medications
* delivering best-in-class proprietary pharmaceutical technologies
* transforming ocular drug delivery
We See You.
Your wellbeing
Your professional worth
Your future at EyePoint
EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.
The Regulatory Affairs specialist will be working under the supervision of the Director of Regulatory Strategy to perform operational tasks related to clinical trial applications and IND activities such as:
* Review of country adaptations of documents (in English) against approved master documents to ensure consistency and accuracy
* Tracking of documents/ submissions
* Administrative support in answering regulatory queries
This role will report to the Director, Regulatory Strategy. This is a one-year contract.
This position is located at our Watertown, MA site. We offer a hybrid work schedule.
Responsibilities
Primary responsibilities include, but are not limited to, the following:
Individual responsibilities
Primary responsibilities include, but are not limited to, the following:
* Under supervision of Regulatory Strategy Director, prepare and check documents for IND clinical amendments for accuracy and completeness
* Review of country adaptations of documents (in English) against approved master documents to ensure consistency and accuracy
* Tracking of documents/ submissions
* Administrative support in answering regulatory queries
Qualifications
Primary skills and knowledge required include, but are not limited to the following:
* Excellent attention to details
* Organization skills
* Collaborative team player
* Strong knowledge of using MS Word
* Proficient in MS-Office Suite and Adobe Acrobat Pro application.
* Ability to balance multiple tasks to meet priorities and timelines.
* Self-starter with superior time management skills, and ability to work independently or in teams.
Level of Education Required:
* BA/BS degree or equivalent
Number of Years of Experience in the Function and in the Industry:
1-3 years' experience in the biotech/pharma industry of which at least 1 year drug regulatory affairs or supporting clinical operations
Envision Your Future
With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.
The collective power of our values influences everything we do, and everything we do for you.
Transformational Innovation
We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.
Unwavering Integrity
We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.
Compassionate Excellence
We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.
Inclusive Collaboration
We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.
EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
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