Clinical Operations Scientist

Location:

Allegan, MI, US, 49010

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.

External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

Description Overview

Perrigo’s Biopharmaceutics and Scientific Substantiation group is involved in the research and development of variety of self-care products which includes various dosage forms of non-prescription pharmaceutical drug products, dietary supplements, and wide range of other self-care products. In addition, team also manages clinical and pre-clinical studies to support the development of new infant nutrition formula. The development of such products requires, knowledge of conducting clinical and pre-clinical studies, evaluation of scientific literature and understanding of clinical data for scientific substantiation. we are seeking a highly motivated, qualified, research-oriented professional that will bring in expertise, resourcefulness, and creative approaches to support and further clinical operations and scientific substantiation program.

Scope of the Role

Clinical and pre-clinical studies management.
Review scientific literature and summarize necessary information to substantiate product claims
Manage and coordinate studies required to substantiate product claims.
Assist in managing sensory and consumer safety clinical research studies to support new and reformulated products.
Interface with key functional groups and CROs to approve protocols related to study objectives.
Provide support for structure functional claims either through information from scientifically robust publications or invitro and/or ex-vivo and/or invivo studies.
Interpret and analyze the study data to present to corresponding stake holders.
Act as liaison between Perrigo functional groups and study centers
Monitor and over see the study conduct and report back to management.

Experience Required

Bachelor’s degree in Biomedical Sciences, Clinical Science or related field.
At least 3 years of experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment
Thorough knowledge of clinical and pre-clinical studies requirements and experience in management of those studies.
Experience in writing clinical study protocols and clinical study reports.
Prior experience in conducting clinical studies and IRB requirements is must.
Deep understanding and familiarity of medical, scientific, and/or epidemiology research techniques and principles
Thorough knowledge in GCP requirements, preferably GCP certification
Awareness of ICH and FDA guidelines on clinical studies conduct.
Experience with literature search and/or review activities for pharmaceutical, clinical research, public health, or academic research

External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better. #DIV