In a landscape where dynamic change is the only constant, we help pharmaceutical and life science companies look beyond the boundaries of the present. We work as a team, spanning projects from molecule to medicine cabinet, anticipating incipient industry trends - then harnessing them.
We are a global, mid-stage pharma and diagnostics services organization that is leading the industry in providing tailored solutions to diagnostic, biotech and pharma organizations whose focus is to develop and commercialize creative products in the new era of precision medicine. We have ~2,100 employees globally, and is led by a team of successful industry veterans.
We understand that the route from assay development to commercialization is complex. Our comprehensive suite of solutions is designed to help our clients with novel or advanced in vitro, laboratory-developed, and companion diagnostics take the shortest path from test concept through clinical trial development, and over regulatory hurdles to regulatory approvals and market uptake.
We focus on the end from the very beginning, cutting through clutter and helping our clients reach their goal faster. Our integrated team understands how the pieces fit together, and ensures that findings from each stage inform the rest of the process.
In this role you will apply your extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions.
How You Will Make an Impact:
- You will lead the preparation of in vitro diagnostic submissions and design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients.
- You will review and lead the development of analytical and clinical protocols, technical reports and other documents for use in regulatory submissions and in response to queries from regulatory agencies.
- You will collaborate with external thought-leaders and technical experts to support research and development, regulatory authorization, and marketing
- You will provide program essential tools such as project plans, communication plans, etc.
- You will inspect regulatory communication, submission, timeline and approval requirement documents
- You will apply quality systems expertise to guide clients towards successful readiness to market products in a regulated environment
- You will generate new business through your own network
- You will work with the management team to design and develop customized, program recommendations and preliminary strategies for inclusion in client proposals
- You will lead workshops and conference curriculums in the areas of translational and regulatory science for in vitro diagnostics
- You will partner with the business development team to support the evaluation of requests for proposals and consider regulatory strategies that can be used and regulatory approval timelines
- You will work with the business development team with client bid defense meetings by communicating the key regulatory considerations of the program to the project team and assisting with the development of the presentation materials for these meetings
- You will be a regulatory compliance subject matter expert who can speak to the strategic positioning and considerations of the program within the healthcare marketplace and who can discuss the established precedents from other similar programs
- You will identify client needs and develop solutions by gaining an understanding of the client’s product, the brand objectives and other relevant industry trends
- You will stay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of business by identifying market trends, new ways of thinking, etc.
- Bachelor’s degree in Life Sciences or equivalent work experience
- Minimum 5 years of applicable consulting experience with a focus in regulatory affairs
- Minimum of 7 years of experience working in a IVD, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment
- Strong written and verbal communication skills
- Strong leadership, team building and interpersonal skills
- Strong business and financial acumen
- Strong scientific and analytical skills
- Ability to think outside of the box and solve hard problems with effective solutions
- Direct experience working with small and large companies to design global regulatory and commercialization strategies
- Experience managing staff members and project teams
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.