Scientist, Scientific Affairs Puerto Rico
Unicity USA
About Us
Unicity is dedicated to developing innovative science-based products and programs that promote metabolic health and improve the quality of life for people everywhere. For over 30 years Unicity has been dedicated to developing high-quality products that contain the vital nutrients your body needs. With the proper process cutting-edge technology and a mission to Make Life Better Unicity is paving the way for a better tomorrow.
Benefits
In addition to competitive pay we offer:
- Health dental vision life and other benefits that begin within a month
- Paid parental leave
- Generous vacation allowance in addition to company-paid holidays
- 401(k) with company match
- Substantial company product allowance
Responsibility:
The Scientist Scientific Affairs will be a resident expert on health and nutrition matters including providing guidance on the technical validity of claims technical assessment of bioactive ingredients and coordination of research programs internally and with external partners including design and execution of fit-for-purpose clinical studies.
Youre Right For This Job If You Can:
- Serve as the scientific subject matter expert for internal teams on functional benefits ingredients formulations and product positioning including risk assessments.
- Assess the current portfolio and recommend improvements in ingredients and functional benefits and develop new product and ingredient claims and health and nutrition propositions.
- Track emerging health trends and new research and share insights and future opportunities with leadership.
- Validate the safety efficacy and regulatory status (e.g. GRAS NDI) of botanical and bioactive ingredients.
- Design fit-for-purpose studies: match the research question endpoints population and study size to the claim the timeline and the budget.
- Independently lead internal studies real-world evidence and consumer studies and decentralized clinical research. This includes writing protocols informed consent forms and IRB submissions and overseeing study conduct data quality and analysis.
- Coordinate external scientific and clinical testing and build relationships with key opinion leaders and clinical research organizations.
- Develop and substantiate claims to FTC and FDA standards support claims review for international markets (e.g. EFSA Health Canada) and build substantiation procedures and documents with R&D Regulatory and Legal.
- Translate science into accurate compliant content and training for marketing sales and distributors. Review and approve marketing content and advertising for technical accuracy and present at company events.
- Prepare reports white papers and publications that accurately represent internal and clinical study results.
Youll Thrive in This Role If You Can:
- Design fit-for-purpose studies that are scientifically valid and support target claims within feasibility timeline and budget constraints
- Make informed decisions with limited or emerging evidence and iterate quickly
- Work independently and take ownership of projects from start to finish
- Partner with marketing R&D and the executive team including recommending defensible alternatives when a claim is not supported
- Think creatively to differentiate products in a crowded market
Qualifications
- Masters of Science (M.S.) or Doctor of Philosophy (Ph.D.) degree or higher in a technical field (nutrition biochemistry chemistry exercise and sports science food science biology etc.)
- Masters with 3 years or Ph.D. with 1 years of clinical research experience
- Ability to search understand and apply the scientific literature in developing science-based products to maintain and improve human health
- Extensive knowledge of human health and current trends in the nutraceutical industry
- Good interpersonal analytical and organizational skills
- Must have strong oral and written communication skills including the ability to explain science to non-scientific audiences
- Understand GCP ICH E6 and HIPAA requirements
- Working knowledge of dietary supplement regulations (DSHEA) and FTC and FDA standards for claims substantiation
- Ability to develop study protocols and procedures required in all aspects of conducting scientifically valid internal and external studies
- Working knowledge of statistics
- Preferred: experience in dietary supplements functional foods pharma or a CRO; IRB submissions; peerreviewed publications
Location and travel: Our ideal candidate can travel and work in-office as needed to conduct internal studies at our Provo Utah or Las Vegas Nevada offices. We are open to remote work for the right candidate. Travel: up to 20% for study sites conferences and company events.
Required Experience:
IC
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