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Regulatory Project Manager — Pharmaceutical (Remote/Onsite — Indianapolis, IN) Contract

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Indiana (USA), United States

Offer summary

Qualifications:

3+ years of regulatory project management experience, In-depth knowledge of clinical trial regulations, Experience in market research and policy analysis, Exceptional attention to detail.

Key responsabilities:

Monitor changes in clinical trial regulations
Develop and implement compliance strategies
Conduct in-depth market research
Assess impact of new regulations on projects
Anticipate regulatory issues and propose solutions
Provide guidance based on regulatory knowledge

Pharmavise Corporation http://www.pharmavise.com

11 - 50 Employees

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Job description

This is a remote position.

Our Fortune 500 Pharmaceutical client has an exciting opportunity for Regulatory Project Managers. 

Job Summary:

We are seeking a detail-oriented and strategic Regulatory Project Manager to support a project with one of our clients in their Clinical Trial Patient Engagement Team. This role is critical in monitoring the evolving clinical trial regulatory landscape and ensuring compliance with current regulations. The ideal candidate will conduct impact analyses, develop proactive response strategies, and stay updated on the latest drug development trends, policies, and regulatory changes to guide project decision-making. 

Key Responsibilities:

Regulatory Landscape Monitoring: Continuously track and analyze changes in the clinical trial regulatory environment and evaluate their potential impact on ongoing and future projects.

Response Strategy Development: Develop and implement strategies to ensure compliance with evolving regulations and industry standards.

Research & Market Analysis: Conduct in-depth research on public websites, regulatory updates, and drug development trends to stay informed of industry shifts.

Impact Assessment: Use market research to assess the effect of new policies and regulations on current and upcoming clinical trial projects.

Strategic Thinking & Problem Solving: Apply critical thinking to anticipate regulatory challenges and proactively propose solutions to ensure smooth project progression.

Regulatory Knowledge: Maintain a thorough understanding of clinical trial regulations, processes, and policies, providing insight and guidance to support decision-making across teams.

Qualifications:

Minimum of 3+ years of experience in regulatory project management, clinical trials, or drug development.

In-depth knowledge of regulatory environments related to clinical trials and drug development.

Proven experience in market research, policy analysis, and regulatory impact assessment.

Exceptional attention to detail and the ability to manage multiple projects and priorities simultaneously.

Excellent communication and interpersonal skills for interacting with cross-functional teams and stakeholders.

Other Details: 

Schedule: Full time, 40 hours per week

Contract Length: 18 months with renewal

Work Setup: Indianapolis preferred, but will consider Remote for very strong candidates

Resources Needed: 2

E-Verify Participation:

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.