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Senior / Regulatory Affairs Consultant - Nonclinical Writer

Parexel International Corporation

United States of America - Remote - Northeas

Are you a Nonclinical professional with a flair for Regulatory Writing?

If so, we have a great home-based opportunity to join Parexel's highly esteemed Regulatory team as a Senior / Regulatory Affairs Consultan t. Our Regulatory Team provides clients with the strategies and services around defining and executing the most efficient path to obtaining regulatory approval.

As a Senior / Regulatory Affairs Consultant, you will be working with a Team of highly experienced professionals with both Industry and FDA experience; you will have the opportunity to work with a variety of clients and products; you will have the opportunity to find solutions and execute on behalf of our clients; you will have the support of a dedicated team of Business Development Professionals; and you will have the opportunity to continue to advance professionally and stretch your own thinking.

A Senior / Regulatory Affairs 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 regulatory services Parexel provides. A Senior / Regulatory Affairs 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 issuesEnsures the timely performance of work within a project scope to the quality expectations of Parexel and the clientAnticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.

Project ExecutionWorks within a team environment or individually based on the project needsWorks within broad project guidelines and facilitates issue and conflict resolutionsPrioritizes own workload and may prioritize the workload of the project team in order to achieve the project scopeCapitalizes on opportunities to improve project efficiency, results or team performance and proactively takes actionLeverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisionsProduces quality work that meets the expectations of Parexel and the clientReviews the work of colleagues for content and quality to ensure the expectations of the client and Parexel are metManages small projects and may manage larger projectsInteracts with the assigned Project Assistant to ensure accurate financial management and for general project supportProvides guidance to project team members, and acts as a mentor to junior staff

Consulting Activities and Relationship ManagementDemonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvementsProvides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clearCompletes 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 satisfactionFacilitates client decision making by framing issues, presenting options and providing objective business adviceCollaborates with colleagues to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower-leve colleagues on appropriate methods of executing project activitiesActs as a trusted advisor to clients and/or project team on technical and/or process issuesDevelops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry driversInteracts professionally at multiple levels including senior management within a client organizationSuccessfully penetrates executive management levels or other business units within a client organizationFacilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problemsDelivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in new business/referralsIdentifies opportunities for follow-on business or changes in project scope

We are looking for individuals that have: 5-7+ years’ experience in an industry-related Regulatory Affairs environment; Pharmaceutical/Biotechnology, CRO, or Consulting industries (level of experience and depth of nonclinical authoring experience will determine level)Previous non-clinical, toxicology, or pharmacology regulatory writing experience to include experience independently authoring:pIND – MRL, BDIND – IB, Modules 2.4, 2.6.1, 2.6.2, 2.6.3, 2.6.4, 2.6.5, 2.6.6, 2.6.7, 4NDABLACDPSPAPast experience interacting and submitting to the FDAA dedication to public health and a passion for drug developmentPrevious Cell and Gene Therapy experience is a plus!

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

When appropriate, the ability to travel up to 20% internationally and/or domestically may be required

#LI-REMOTE

Job posted: 2022-10-18

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