Careers

REGULATORY AFFAIRS / SCIENTIFIC CONSULTANTS

About this Job

Regulatory Affairs Consultants needed:

Expand your experience and knowledge base in the fields of biotech and medical technology. 

Be an agent for change in healthcare !

We are seeking professionals and recent graduates in Regulatory Affairs, Biochemistry, Cell Biology, Business, and Marketing to expand our consulting services range.

Our goal is to provide world class regulatory and scientific support to biotech and med tech firms to improve the state of healthcare worldwide.

Our Regulatory Consultants will be providing scientific, business and technology support to our operations and to client projects in biotech and medical device firms.  You’ll be “in the room” when decisions are being made on healthcare innovations and developing of new strategies for product development.  You’ll be helping Cerneos with marketing our services and those of our clients and providing the scientific and regulatory support needed for product development.  We’ll provide you with support for career networking, project management and communications skill development in a variety of fields including:

Cell Biology, Immunology, Molecular Biology 

Regulatory Affairs

Public Health

International Business

Social Media and Communications

Qualifications: 

  • Experienced professionals or recent graduates in regulatory affairs, clinical affairs or quality assurance.
  • 2 -5 years or biotech/medtech business or scientific/regulatory experience in industry or coursework.
  • Able to work remotely and collaborate via ZOOM, TEAMS, Google Meetups or other platforms
  • Excellent written and verbal communications skills and ability to communicate across disciplines
  • Demonstrated project management, collaboration and team building skills
  • Ability to use networking and literature research to answer research questions.
  • Able to work for any employer in the USA as compensated 1099 contractors.

Regulatory/Scientific Expertise Required:

  • Strong scientific background in cell and molecular biology, immunology or engineering
  • Regulatory experience in global strategy, regulatory submissions, technical writing, CMC and regulatory documentation
  • Experience with 510(k), PMA, IND, BLA, NDA, ANDA and DeNovo submission strategy, writing, planning and submissions.
  • Literature research capability and familiarity with bioscience industry
  • Ability to review research papers, regulatory standards and publications to answer questions.
  • Prefer familiarity with US, EU and International standards for product development, clinical trials and manufacturing

Business and Marketing Consultants: 

Use your business, marketing and social media skills to improve outreach, expand our brand.  Share your expertise with exciting new innovative firms in Biotech, Medical Devices and Diagnostics. 

You will be providing marketing, branding, business development and media services to Cerneos Group and Cerneos clients.  You will drive marketing and business programs for Cerneos and clients and position clients as part of our global services.  You will be coordinating media, nonprofit and public relations activities with professional associations, clients and our strategic partners.  You’ll help clients present their products and services and project the Cerneos brand through social media, education programs, webinars and events.

Expertise Required:

  • Social Media experience for branding and positioning
  • Development of websites and media such as podcasts, webinars, social media posts
  • Familiarity with business finance skills for business plan development
  • Ability to interpret trends in biotech and medtech to identify opportunities for marketing

Projects and Opportunities:

  • Attendance at scientific meetings and conferences to summarize meeting information.
  • Utilize social media and networking skills to identify project resources and collaborators
  • Provide assistance to business and regulatory consultants on client projects
  • Use internet, social media, database searches and regulatory guidances to answer questions.
  • Prepare research reports, short articles and white papers on a variety of business, scientific and regulatory topics.
  • Maintain lists of contacts, projects and marketing data needed to operate consulting firm.
  • Utilize MIRO, Microsoft and Trello tools to organize projects
  • Assist in the development of client reports and project team meetings
  • Maintain project logs and reports, track hours and maintain contact with Cerneos consultants
  • Ensure confidentiality of Cerneos and client information

Commitment

  • Assignment durations vary depending on client needs.  Average is 5-10 hours per week according to your availability
  • Flexible scheduling for September 2021 to December 2022
  • Request 2 week notice before leaving assignments.

Benefits

  • Expanding your skills in a supportive and supervised environment and working in teams with other Cerneos Consultants.
  • Free attendance to scientific meetings and conferences
  • Networking with industry leaders in the life sciences
  • We’ll help you with career networking, communications skills and job prospecting
  • Assignments will be made based on your professional and academic interests
  • This program will add to your resume and provide you with real world experience.

You’ll be working from home according to your availability in a virtual environment. We’ll give you on the job training and provide you with the networking leads to help you to the next step in your career.

About The Cerneos Group, LLC

Global Compliance for the Life Sciences

Biotech and Medical Device Regulatory and Product Development Consulting team.  We provide regulatory services to innovative firms in biotech and medical devices.  Our goal is to improve health by the development of innovative healthcare products and services.  We are the interface between an innovative firm and the FDA and other international health authorities.

To learn more about opportunities and apply for positions, please send:

Professional Profile 

Description of your career goals

Resume/Cover Letter

Linkedin Profile

Apply online to rtharin@cerneos.com:

http://cerneos.com

(2) Senior Consultant | Cerneos Group | LinkedIn

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