Regulatory Affairs Consultant

Company: Innovative Science Solutions, Inc.
Location: Morristown
Posted on: February 24, 2021

Job Description:

Innovative Science Solutions, Inc. (ISS) a Cello Health business is a boutique scientific consulting company serving the worldwide pharmaceutical, biotechnology, and medical device industries. We are a team of scientists, regulatory strategists, and consultants providing a wide range of fully integrated scientific consulting services to industry and counsel.--From FDA Advisory Committee meetings to complex litigation support, ISS delivers specialized solutions for business hurdles.--For more information about our firm visit us at--www.innovativescience.net.You have high expectations for yourself and your career, so does ISS. Imagine what we will achieve together.Responsibilities: * Identify and analyze clinical/regulatory information to support a variety of projects* Ensure accuracy and quality of work product deliverables* Create and execute regulatory strategies* Develop insightful and meaningful written and/or oral critical analysis of regulatory issues* Provide project oversight and ensure that projects stay within budget parameters* Communicate with clients to convey project status, interim reports and final project deliverables* Conceive, formulate and implement effective marketing initiatives designed to sell our company's servicesQualifications:The ideal candidate is inquisitive, ambitious, hardworking and has a strong healthcare regulatory experience along with the following:* Advanced degree preferred in a life science or related field and 2-5 years relevant experience in regulatory affairs, medical affairs or clinical research* Proficient and comfortable with scientific/medical data and nomenclature* Ability to effectively communicate complex scientific and regulatory principles to non-scientists (as well as to scientists and healthcare professionals)* Relevant work experience; preferably in regulatory affairs and/or project management; previous experience with regulatory submissions, regulatory body meetings (e.g. FDA Advisory Committees) a plus* Proficient with Word, Outlook, Excel, and PowerPoint* Expert skills in internet searching and web browsing* Eagerness to work independently and in teams in a fast-paced environment* Excellent ability to interpret scientific charts, tables and figures* Passion for producing and presenting scientific data in oral presentations or written reports* Excellent communication skills

Keywords: Innovative Science Solutions, Inc., Newark , Regulatory Affairs Consultant, Professions , Morristown, New Jersey