Regulatory Affairs jobs in United States

Job Description

Principal Scientist (Director) Outcomes Research – Women’s Cancer

Under the guidance of a senior leader, the Principal Scientist (Director), Outcomes Research—Women’s Cancer will be a member of the overall team responsible for an asset-level strategy and plan. Will develop and maintain tumor and indication expertise relevant to the asset. Will assess unmet medical need and value across tumors/indications for the asset for asset-level tumor/indication prioritization discussions.

Types of studies executed include prospective and retrospective observational studies to characterize disease burden and epidemiology, treatment patterns, healthcare resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, and systematic reviews and meta-analyses. Incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that product value is defined and developed to achieve optimal market/patient access and reimbursement. The incumbent is expected to work cross-functionally with clinical development, medical affairs, biostatistics, market access, commercial and country affiliates and may have direct interactions with health technology assessment (HTA) agencies and reimbursement decision makers.

Primary Responsibilities:

• Lead in value evidence teams in Women’s Cancer and contribute to value evidence strategies. Obtain senior management approval of evidence generation plans. Provide outcomes research leadership on cross-functional regional and global teams.

• Aligns with alliance partner(s), as necessary.

• Critically assess drivers and barriers to reimbursement and market access, and provide input into clinical, regulatory, payer/access, marketing and evidence generation strategies and programs.

• In collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.

• Responsible for study-related contracting, and budgets.

• Develop supplementary clinical data package in close partnership with markets and HTA statistics group for submission to HTA agencies.

• Support country affiliates to understand local evidence generation needs, adapt health economic evaluations, customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements.

• Work closely with cross functional teams to effectively communicate outcomes research and health economic modelling data internally and to external stakeholders.

• Maintain awareness of new scientific and methodological developments within therapeutic area.

• Build relationships with scientific experts worldwide.

• Present outcomes research data at national and international congresses and publish articles in scientific journals.

Qualifications & Experience

Preferred: Doctoral degree (PhD, DrPH, ScD, PharmD) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration) with a minimum of 4 years of experience post degree.

Required: Masters degree (MSc, MPH) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration) with a minimum of 6 years of experience post degree.

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$187,000.00 - $294,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Data Management, Researching, Stakeholder Relationship Management, Strategic Planning

Preferred Skills:

Job Posting End Date:

05/21/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.