This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Senior Regulatory Affairs Generalist - Digital Health

Parexel International Corporation

USA - Any Region - Home Based

We are currently looking for experienced Regulatory Affairs Generalists who are looking to build upon their Digital Health experience and work as a dedicated partner to a dynamic client with a broad portfolio! If you are passionate about drug development and committed to making a difference, this role will draw upon your Regulatory Affairs expertise while taking your career to the next level!

A Senior Consultant must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services PC (Parexel Consulting) provides. A Senior Consultant develops specialist knowledge of a particular subject matter or market.

•Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.

•Provides guidance to project team members on technical/process issues

•Ensures the timely performance of work within a project scope to the quality expectations of PC and the client

•Anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.

Project Execution

•Works within a team environment or individually based on the project needs

•Works within broad project guidelines and facilitates issue and conflict resolutions

•Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope

•Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

•Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions

•Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met

•Manages small projects and may manage larger project engagements

•Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support

•Provides guidance to project team members, and acts as a mentor to junior staff

Consulting Activities and Relationship Management

•Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements

•Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear

•Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction

•Facilitates client decision making by framing issues, presenting options and providing objective business advice

•Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities

•Acts as a trusted advisor to clients and/or project team on technical and/or process issues

•Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers

•Interacts professionally at multiple levels including senior management within a client organization

•Successfully penetrates executive management levels or other business units within a client organizatio

QualificationsDescription continued:

•Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems

•Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals

•Identifies opportunities for follow-on business or changes in project scope

Qualifications

We are looking for individuals that have:

•10+ years’ experience in a Regulatory Affairs role in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries with 1-2 years’ experience working on Digital Health products (Medical Device Software and Connected Devices)

•Previous pre and/or post approval Regulatory Affairs pharmaceutical product experience

•Familiarity/experience with FDA interactions to include past experience ensuring client's and/or company's best interest are represented

•Past experience developing regulatory strategy for medical device software and connected delivery systems is a plus

•Prior experience leading and/or contributing to authoring regulatory submissions

•Excellent oral and written communication skills

•Previous experience working with internal and external client teams to ensure regulatory issue are identified, communicated, and addressed

•Exceptional candidates with 5+ years of related experience will be considered at the Consultant level

Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred

Language Skills - At least fluent vocal and written English

Up to 30% Travel may be Required

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2020-11-06

3