Job details
Job type full-time
Full job description
***this is a home or office-based positionCandidates can be from anywhere in the us and/or the eu.
Iqvia is changing an entire industry through inspired innovationOur people make the differenceWe believe that great ideas can come from anywhereGreat products come from great ideasAnd great ideas come from great peopleWe look for the very best people and then give them meaningful work to doJoin iqvia and help us make the world a better place.
Purpose
The clinical/data scientist position is intended for an individual aspiring to lead product development programs within the pharmaceutical industryYou will have responsibility for preparation of various products of the strategic drug development group that are part of the product development process.
These include: integrated product development plans; sections of investigational new drug (ind) applications; clinical study synopses and protocols; investigator brochures; supporting statistical documents; sections of marketing applications; target product profiles (tpps); clinical development plans (cdps); asset and indication prioritization.
Responsibilities
Duties of the clinical/data scientist include:
Providing support and/or leadership for key deliverable outputs.
Driving and/or writing key documents in support of drug development projectsDocuments include gap analyses, protocol synopses, fda meeting request letters (mrls)Fda meeting information packages (mips), cdps, and tpps.
Researching current literature, including current product label, treatment guidelines, competitive landscape assessments and standard of care, to assist in the drug development lead in preparation for all deliverables.
Summarizing animal and clinical studies to facilitate evaluation of the potential safety and efficacy of the drug under study.
Supporting the drug development lead in assembling powerpoint slides for client deliverables including indication prioritization, clinical development plans and target product profiles and contributing to the scientific decision making for the asset(s) various sections.
Assisting in writing documents to support regulatory submissions including, but not limited to, clinical trial authorizations (inds, ctas), investigator brochures and protocols, marketing authorization applications (ndas, blas, ndss, maas), device authorizations (ides, 510ks, pmas).
Developing templates for key deliverable outputs.
Locating, extracting, and analyzing public and proprietary data to create datasets and outputs that support key drug development deliverables including, tpps, cdps, asset prioritization, and indication prioritization.
Required knowledge, skills and abilities
Masters degree (or equivalent)A phd or pharmd is preferred.
Experience with medical, pharmaceutical, or scientific research concepts.
Minimum of two years’ work experience (e.g., student internships, postdoctoral fellowships, laboratory positions, or project management).
Experience with principles of, or project work involving, chemistry, manufacturing, and controls (cmc), nonclinical safety research, or clinical study design, management, or participation is desirable.
Excellent reasoning capabilities and scientific acumen.
Proficiency in scientific writing (outlining, drafting, revising, and reviewing).
Working knowledge of medical terminology and basic statistical concepts.
Experience in using and presenting clinical, scientific, or business data to provide evidence for research and decision-making.
Proficiency with software applications including microsoft powerpoint, excel, word, project, outlook, teams, and visio.
In addition, the successful applicant must be:
Detail-oriented, thorough, and methodical.
Able to reduce complex scientific data to its essence in tabular or summary form.
Flexible and adaptable to changes in work duties, responsibilities, and requirements.
Team-oriented, keeping others informed of the progress and status of projects.
Able to focus on strategic objectives in a dynamic environment.
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At iqvia, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier worldThe advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the wayLearn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
Iqvia, incProvides reasonable accommodations for applicants with disabilitiesApplicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact iqvia’s talent acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.
