Why Join a Global Leader in Life‑Sciences Talent?
At Workwarp, the world’s largest staffing and recruitment agency, we empower professionals to accelerate their careers in the rapidly evolving life‑sciences arena. Our mission is to connect top talent with innovative biopharmaceutical organizations that are transforming patient care worldwide. Our partner in this role is a research‑driven biopharma powerhouse that has brought 32 life‑changing products—such as Humira and Lupron—to market, delivering hope to millions of patients living with complex, hard‑to‑treat diseases.
When you join this elite team, you become part of a culture that values scientific rigor, regulatory excellence, and a relentless focus on patient outcomes. We provide an environment where you can deepen your expertise, influence critical medical‑review processes, and collaborate with world‑class scientists, clinicians, and regulators—all from the comfort of your own home.
Position Overview
The Remote Senior Medical Reviewer & Safety Review Specialist – Level III is a pivotal role that sits at the intersection of medical affairs, promotional compliance, and drug safety. Reporting directly to the Medical Affairs Leader, you will represent the medical affairs function throughout the Medical, Legal, and Regulatory (MLR) review workflow, ensuring that all commercial and educational materials meet the highest standards of scientific accuracy, regulatory compliance, and ethical responsibility.
This is a contract opportunity based in North Chicago, Illinois, with a competitive hourly rate ranging from $39.00 to $51.65 and a typical workday of 9 AM – 5 PM. The role offers immediate start dates for qualified candidates and provides a clear pathway for professional growth within the organization.
Key Responsibilities
As a senior reviewer, you will be accountable for a wide spectrum of activities that safeguard the integrity of medical communications. Your daily responsibilities will include, but are not limited to:
- MLR Review & Compliance: Conduct thorough medical review of promotional, educational, and digital content, verifying alignment with internal policies, FDA regulations, and global guidelines (e.g., ICH, EFPIA). Document findings, suggest revisions, and negotiate with cross‑functional stakeholders to achieve final approval.
- Promotion Material Management: Utilize Veeva Vault PromoMats and Med‑Com platforms to upload, track, and maintain version control of all marketing assets. Ensure that every piece of material—brochures, slide decks, webinars, social media posts—passes rigorous scientific scrutiny before release.
- Support Clinical & Medical Initiatives: Partner with Medical Science Liaisons (MSLs), medical education teams, and digital communication groups to develop scientifically accurate content for conferences, webinars, and peer‑to‑peer interactions.
- Project Leadership: Lead assigned projects from inception through delivery, establishing timelines, allocating resources, and reporting status to senior leadership. Employ project‑management best practices to meet deadlines while maintaining quality.
- Cross‑Functional Collaboration: Engage with regulatory affairs, legal, marketing, sales, and clinical research teams to harmonize messaging and ensure consistent scientific messaging across all channels.
- Safety Review Integration: Coordinate with drug‑safety teams to incorporate the latest pharmacovigilance data into promotional and educational materials, ensuring that risk‑benefit information is current and accurately presented.
- Continuous Improvement: Identify gaps in the MLR process, propose enhancements to standard operating procedures (SOPs), and champion best‑practice initiatives that elevate compliance and efficiency.
Essential Qualifications
The ideal candidate brings a blend of scientific expertise, regulatory acumen, and strong communication skills. The following qualifications are required:
- Education: Bachelor’s degree in a life‑science discipline is mandatory; an advanced degree (PharmD, PhD, PA, or NP) is strongly preferred.
- Experience: Minimum of 3 years of hands‑on medical review experience within the pharmaceutical industry, with a proven track record in promotional material review. Experience with Veeva PromoMats and Med‑Com is highly desired.
- Scientific Knowledge: Demonstrated ability to interpret complex clinical data, understand the patient treatment journey, and translate scientific evidence into clear, compliant messaging.
- Regulatory Insight: Familiarity with FDA, EMA, and other global regulatory frameworks governing promotional materials, alongside internal compliance policies.
- Communication Skills: Exceptional oral and written communication abilities, with experience presenting technical information to both scientific and non‑scientific audiences.
- Leadership & Collaboration: Strong interpersonal skills, capable of influencing cross‑functional teams and driving projects to successful completion.
- Analytical Thinking: Acute attention to detail, strong problem‑solving capabilities, and the ability to make strategic decisions based on data.
- Adaptability: Proven success in fast‑paced, dynamic environments, managing multiple priorities and shifting business needs.
Preferred Qualifications & Additional Assets
- Prior experience in psychiatry or mental‑health therapeutic areas.
- Certification in regulatory affairs (e.g., RAC) or related professional credentials.
- Hands‑on experience with digital communication platforms and e‑learning tools.
- Experience in drug‑safety surveillance and integration of pharmacovigilance data into marketing collateral.
- Proven project‑management certification (PMP, PRINCE2) or similar training.
Core Skills & Competencies
- Regulatory & Compliance Acumen: Deep understanding of MLR processes, FDA guidance, and industry best practices.
- Scientific Literacy: Ability to evaluate clinical trial data, safety profiles, and therapeutic landscapes.
- Technical Proficiency: Mastery of Veeva Vault, Med‑Com, Microsoft Office Suite, and collaboration tools (e.g., Teams, SharePoint).
- Project Management: Skilled at creating project plans, risk assessments, and status reporting.
- Stakeholder Management: Expertise in building relationships with internal teams and external partners.
- Critical Thinking: Ability to identify potential compliance issues before they arise and propose pragmatic solutions.
- Effective Writing: Crafting clear, concise, and scientifically accurate statements for diverse audiences.
- Ethical Judgment: Commitment to patient safety, data integrity, and corporate responsibility.
Career Growth & Learning Opportunities
Workwarp and its biopharma partner are invested in your long‑term success. As a Senior Medical Reviewer, you will have access to:
- Mentorship Programs: Pairing with seasoned medical affairs leaders to refine your expertise.
- Continuing Education: Funding for relevant certifications, conferences, and webinars that keep you at the forefront of regulatory trends.
- Cross‑Functional Rotations: Opportunities to shadow regulatory affairs, clinical development, or pharmacovigilance teams, expanding your holistic industry perspective.
- Leadership Pathways: Clear trajectories toward Medical Affairs Manager, Senior Manager, or Director roles based on performance and ambition.
- Innovation Labs: Participation in pilot projects exploring digital therapeutics, AI‑driven compliance tools, and next‑generation medical communication platforms.
Work Environment & Culture
This is a fully remote position, offering the flexibility to work from any location within the United States while staying connected to a vibrant, inclusive community. Our culture is built on:
- Collaboration: Regular virtual huddles, cross‑team brainstorming sessions, and open communication channels ensure you remain integrated with the broader organization.
- Diversity & Inclusion: An equal‑opportunity employer that values varied perspectives, backgrounds, and experiences. We actively foster a workplace where every voice is heard.
- Well‑Being: Access to mental‑health resources, wellness stipends, and flexible scheduling to support work‑life harmony.
- Recognition: Performance‑based incentives, peer‑to‑peer recognition programs, and celebration of milestones.
- Technology‑First: State‑of‑the‑art digital collaboration tools, secure remote access platforms, and robust IT support to keep you productive and secure.
Compensation, Perks & Benefits
While the exact hourly rate will be tailored to experience, education, and geographic location, successful candidates can expect a competitive package that includes:
- Hourly compensation ranging from $39.00 to $51.65 based on qualifications.
- Eligibility for performance bonuses tied to project milestones and quality metrics.
- Comprehensive health benefits (medical, dental, vision) after eligible tenure.
- Retirement savings options, including 401(k) with employer matching.
- Paid time off (PTO) and flexible holidays to recharge.
- Professional development budget for certifications, conferences, and coursework.
- Access to an employee assistance program (EAP) and mental‑health resources.
- Remote‑work stipend covering home‑office setup, internet, and ergonomic accessories.
Equal Opportunity & Accessibility Commitment
Workwarp is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, protected veteran status, or any other legally protected characteristic.
If you need a reasonable accommodation to participate in any part of the recruitment process, please contact [email protected]. We will work with you to ensure a smooth and accessible experience.
How to Apply
If you are ready to leverage your medical review expertise to shape the future of innovative therapies, we invite you to submit your application today. Please provide an up‑to‑date resume, a cover letter highlighting your most relevant achievements, and any supporting certifications.
Applications will be accepted for the next thirty (30) days. Early submission is encouraged, as we will begin reviewing candidates immediately.
Take the Next Step in Your Career
Join a dynamic team where scientific excellence meets regulatory precision. Your contributions will directly impact how life‑saving medicines are presented to healthcare professionals and patients worldwide. Apply now and become a key driver of compliance, safety, and innovation in the biopharma industry.
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