Job Description

　　At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD® clinical research portfolio, our work in evidence-based solutions specializes in generating the evidence needed to optimize the commercial potential of our biopharma and biotech customers' products. Your determination to demonstrate effectiveness, safety and the value of these products will improve health outcomes that people and communities depend on - now and in the future.

　　Location/Division Specific Information

　　The role offers 100% remote flexibility.

　　#Evidera #Remote

　　Discover Impactful Work:

　　The Senior Research Associate (SRA) based in Clinical Outcomes Assessment provides scientific leadership within project teams either independently and/or collaboratively with research scientists, in the conceptualization and execution of COA projects. The SRA participates as an author or internal reviewer of client deliverables, including study protocols, final reports, literature reviews, statistical analysis plans, PRO evidence dossiers, poster presentations, and manuscripts. They also participate in client meetings (face-to-face as well as teleconferences) and provides effective and timely status updates, including identifying issues for escalation. An SRA formulates project work plans, ensures project timelines are met within scope and budget, and are aligned with client expectations. Opportunities to train and mentor junior level staff abound.

　　A day in the Life:

　　Science

　　Drafts abstracts, posters, oral presentations, and manuscriptsConceptually fits individual scientific tasks together to determine how the overall scientific goal will be achievedProficient in methodology around ePRO and translationsWhen presented with qualitative data, designs an analysis plan and generates a report fit for client submissionWhen reviewing instrument development literature, identifies gaps between the development and the FDA guidanceSuccessfully communicates with and advises clientsConceptualizes and drafts, or leads, a complete proposal based on a client idea or RFP.Demonstrates advanced scientific leadership and direction to project teams

　　Project Management

　　Able to identify staff resources required for efficient teams, present the scope of work, and execute the scope by providing direction and feedback to that teamManaging internal timelines to ensure that deliverables meet external client timelinesManaging internal budget/staff hours per project not to exceed contracted budgetKnowledge of project management systems (electronic and paper filing, SOP requirements, finance office practices, IRB needs, etc)Ensures project compliance with paper and electronic filing.

　　Financial & Business Development

　　Leads, reviews, and finalizes project proposals, including budgetModifies proposals in response to client requests for changes and scientific insight for client's strategic needs.Independently develops follow-on business with existing clients

　　Operations Support

　　Attends and presents at scientific conferencesDevelops and presents internal scientific trainingsParticipates in staff recruitment efforts (phone screening, interviewing, attending presentations, etc)Conforms to SOPs and other Evidera/PPD requirements Participate in special assignments (e.g. job descriptions, handbook updates, SOP scientific consulting)Supervises mid-level scientific staff

　　Strategy/Consulting

　　Developing client relationshipsBegins to understand pharmaceutical industry and relationship between divisions as they relate to HE/OR groupsBegins to understand FDA structure and reviewing divisionsProvides scientifically rigorous deliverables that best helps clients meet their objectivesWorks with PI to help identify scientific methods/plans that help clients meet their goals as well as those that will not help clients meet their goalsAssists PIs in preparing clients for regulatory meetings

　　Keys to Success:

　　Education & Experience

　　Doctorate Degree (e.g. PhD; D.Ph.; Pharm D) in science discipline; orMaster's degree in science discipline, with at least 5 years' experience in a relevant field; orBachelor's degree with at least 7 years' experience in a relevant field,

　　Knowledge, Skills, Abilities

　　Ability to manage or direct large portfolio of projects in terms of dollar volume and number of projectsUnderstanding of health outcomes research principles and familiarity with key aspects of the literature (historical and current)Extensive knowledge of practical research implementation (IRB process, data collection and management, knowledge about developing and executing an analysis plan-qualitative and quantitative)Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc)Understanding of instrument development and validation processUnderstanding of relevant qualitative and quantitative methodologyDemonstrates ability to work well within diverse project teamsExcellent communication and scientific writing skills, as demonstrated by peer-reviewed publications, technical reports, or other scholarly workStrong analytical and problem-solving skills

　　Benefits

　　We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Accessibility/Disability Access

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