Director, US Medical Information – Medical Review

BioNTech SE

Director of US Medical Information & Medical Review at BioNTech leading medical review processes and ensuring compliance in pharmaceutical communications.

Posted 6/9/2026full-timeBerkeley Heights • New Jersey • 🇺🇸 United StatesLead💰 $168,100 - $268,700 per yearWebsite

ATS Keywords

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Hard Skills

medical review processesregulatory compliancescientific communicationsmedical information deliverykey performance indicatorsaudit readinessrisk mitigationmultidisciplinary workstreamsSOP developmentprocess transformation

Soft Skills

leadershipmentoringcommunicationnegotiationstakeholder managementteam managementstrategic partnershipinspirationempowermentorganizational skills

Tools & Technologies

digital content review systemsproject management tools

Certifications & Qualifications

PharmDPhDMD

Industry Keywords

pharmaceutical industrybiotech industryEFPIAFSAPhRMAregulatory requirementsscientific excellencepromotional materialsnon-promotional materialscompliance standards

About the role

Key responsibilities & impact

Serve as the principal expert and strategic leader for medical review processes, ensuring the accurate and compliant evaluation of promotional and non-promotional materials, scientific content, and communications.
Establish priorities that align with regulatory requirements, ethical standards, and BioNTech’s commitment to scientific excellence.
Design, implement, and continuously refine robust medical review frameworks and SOPs.
Lead the transformation of legacy systems into streamlined scalable processes that support BioNTech’s innovative pipeline and compliance needs.
Build and manage agile, cross-functional workstreams to support medical review and information activities.
Inspire, mentor, and empower a high-performing, matrixed team of medical reviewers, information specialists, and project managers.
Act as a strategic partner to Regulatory, Legal, Compliance, Commercial, and Scientific Affairs teams, ensuring seamless communication and alignment on pipeline and marketed product strategies.
Lead the development and delivery of scientifically accurate, high-quality medical information to healthcare professionals, patients, and internal teams.
Stay ahead of evolving regulations, guidance, and industry standards. Lead audit readiness and risk mitigation efforts to ensure compliance and operational excellence.
Establish and monitor key performance indicators to measure the impact and effectiveness of medical review and information services.

Requirements

What you’ll need

Minimum of 8 years of experience in the pharmaceutical or biotech industry, with at least 5 years in a medical affairs role
Advanced scientific or healthcare degree (PharmD, PhD, MD, or equivalent strongly preferred)
Proven expertise in developing and leading medical review processes and multidisciplinary workstreams
Strong knowledge of regulatory and compliance requirements for promotional and scientific communications in the pharmaceutical/biotech industry (e.g., EFPIA, FSA, PhRMA)
Demonstrated leadership in building, mentoring, and managing matrixed teams
Exceptional communication, negotiation, and stakeholder management skills.
Experience with digital content review systems and project management tools is a plus.

Benefits

Comp & perks

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more!