Research Associate III Real-World Science, Epidemiology & Scientific Affairs – Pregnancy Studies

Work Schedule

Environmental Conditions

Job Description

TheReal-World Science Epidemiology and Scientific Affairs team focuses on generating real-world evidence and supports biopharmaceutical companies throughout the product lifecycle from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries generate real-world evidence to demonstrate and support the value of their products. Through the generation of real-world data via the design implementation and analyses of observational/non-interventional studies we may provide key information such as:

• Incidence and prevalence of diseases and co-morbidities and their risk factors
• Burden of disease unmet needs
• Treatment patterns and drug utilization
• Healthcare resource utilization
• Overall safety incidence of adverse events of special interest
• Effectiveness and comparative effectiveness data
• Pregnancy safety studies (e.g. pregnancy exposure registries descriptive pregnancy safety studies)

This position will focus on supporting pregnancy safety studies.

Position Overview:

The Research Associate III drafts project deliverables interacts with clients and contributes to strategic thinking under the direction of senior staff. The Research Associate III also supports scientific coordination and project management.

Essential Duties and Responsibilities (other duties may be assigned):

The Research Associate III will bear scientific responsibility for the development of scientific deliverables (e.g. protocols reports) that accurately summarize the study design of de novo data collection projects (retrospective prospective and/or cross-sectional) under oversight of more senior primary focus of this position will be to support pregnancy studies (e.g. pregnancy registries descriptive pregnancy safety studies).

In particular theResearch Associate III will:

• Participate in scientific guidance/consultation onscientificmethodological and operationalconsiderations of project design and conduct
• Lead on or oversee development of project deliverables ( case report forms (electronic or paper)survey questionsreports)forsenior review.
• Interact directly with project sponsors physician expertsandclinical sites if appropriate and under the guidance of senior staff
• Assist theresponsible scientistwith monitoring project budget spend and managing timelines for scientific tasks/deliverables.
• Participate in the development of abstracts and manuscripts
• Contribute to the growth ofProspective Real-World Studiesthrough business development activities includingsupport ofproposal development participation in the sales cycle and when appropriate presentations
• Support otherorganizationalactivities as needed (e.g. supervise and/or mentor junior staff closely collaborate withother project stakeholders such as clinical operations data management biostatistics and data analysts;contribute to development of training materials and process improvements)
• Travel (national and international travel) may be expected

Consulting Expectations:

• Participates in client calls and is expected to be able to address questions posed directly to him/her about his/her work
• Contributes to strategic thinking under the direction of senior staff.

Education Professional Skills & Experience:

• PhD (epidemiology or closely related field) or MSc with 1-5 years of relevant experience; advanced degree in perinatal epidemiology or equivalent training and/or experience in pregnancy highly desirable
• Experience withde novodata collection (field) projects (non-interventional designs in particular) is highly desirable
• Good understanding of epidemiologic methodology
• Previous experience in consultancyand/or CROenvironment highly desirable
• Working knowledge ofMS Office software;working knowledge ofdata analysis software (e.g. SAS Stata R)a plus
• Experience with design of peri- or post-approval late phaseinterventionalprojects is not required but would be considered a plus

Personal Skills & Competencies:

• Demonstrated ability to communicate and document information effectively in written English including the ability to producescientificreportspresentationsemails and other writtendeliverablesthatare well-organized free from errors and are appropriately adjusted to the characteristics and needs of the audience.
• Strong organizational time-management prioritization and decision-making skills necessary to evaluate plan and accomplish multiple work goals in a timely fashion.
• Able to quickly learn and apply new information skills and procedures.
• Proactive and positive approach to tasks and projects as well as resilience when encountering process project budget or client changes that are inherent in the consulting environment.
• Strongcommunication and interpersonal skills including the ability to quickly develop and sustain positive rapport with internal and external contacts in person over the phone and by email.
• Experience presenting ideas to individuals and groups in a formal presentation setting
• Delivers a positive internal/external client experience; listens and understand the clients needs and recommends solutions
• Demonstrates sound professional judgment in analyzing responding to and resolving enquiries issues and escalations.

PPD part of Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary for typical working hours.

• Ability to use and learn standard office equipment and technology with proficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May require travel. (Recruiter will provide more details.)

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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