Social & Scientific Systems (S-3)

Regulatory Compliance Specialist

US-MD-Silver Spring
Job ID
2017-1680
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

Responsibilities

 

  • Develop portions of complex service contract solicitations and reports;
  • Provide knowledge of principles, laws, statutes, Executive Orders, regulations, and procedures relating to contracting and medical research;
  • Advise on industry standards including commonly required personnel, regulations, and tasks;
  • Research new technologies that support branch mission, summarize results, and advise on industry standards and regulations;
  • Provide guidance and assistance in drafting statements of objectives (SOOs), statements of work (SOWs) performance work, statements (PWSs), justification and approvals (J&As), and with the conduct of acquisition planning and market research activities;
  • Contribute to proposal SSS development
  • This is a nonsupervisory position.

Qualifications

  • Bachelor's Degree in a technical or business area plus five years research and/or regulatory related work experience;
  • Ability to rewrite complex medical research terminology and concepts for lay audiences
  • Knowledge of a wide range of contracting methods and contract types;
  • Broad understanding of medical research, from in situ to clinical trials.
  • Knowledge of grant and contract administration, fiscal management, and budget preparation. Experience in proposal preparation a plus.

Knowledge, Skills and Abilities:

  • Must have excellent verbal and written communication skills; excellent interpersonal and client management skills
  • Strong working knowledge of GCPs, ICH guidelines, FDA and/or EU guidelines
  • Excellent organizational and time management skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel and PowerPoint, MS Projects a plus
  • Must possess a professional and customer service oriented demeanor
  • Experience working in matrix environments; ability to work well in a team environment
  • Ability to perform job specific responsibilities with minimal supervision
  • Demonstrated problem solving skills, strong sense of urgency and attention to detail

 

SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.