Director/Senior Director - Medical Information

Soterius, Inc.; Oregon; Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Leadership career path

Client exposure

Team-building opportunities

Competitive compensation

Flexible work arrangements

Job summary

Soterius, Inc. is seeking a Director/Senior Director of Medical Information, remotely across the United States. The role requires 15+ years in life sciences with MI/PV expertise and prior MI leadership experience.

You will oversee sponsor accounts, drive operational excellence, and scale the MI function while collaborating with PV, Quality, Regulatory, and Commercial teams. You will build SOPs, develop global content, and manage client relationships across multiple sponsors.

Qualifications

• 15+ years in life sciences with MI/PV experience.
• MI management or team-lead experience in CRO/pharma/biotech.
• Track record of managing client relationships, SLAs, and audits.
• Experience handling medical inquiries across global markets.

Responsibilities

• Lead end-to-end MI delivery for sponsor clients with SLA and regulatory adherence.
• Be primary accountability for quality, timelines, and compliance across portfolio.
• Oversee medical inquiries via phone, email, and other channels.
• Own quality control of MI responses and handoffs to PV/Quality.
• Lead and mentor a growing MI team and recruit/train Associates.

Skills

Medical Information

Pharmacovigilance

Team leadership

Client relationships

SLA management

Regulatory knowledge

Education

PharmD or equivalent

Life sciences degree

Tools

MI databases

Content management systems

Job description

Director/Senior Director - Medical Information

15-20 years

Remote

Full-Time

Why this role exists

We are seeking a Director, Medical Information to support the delivery and continued evolution of our Medical Information services. This role will be responsible for providing strategic oversight of sponsor accounts, ensuring high-quality and compliant MI operations, and contributing to process excellence and functional growth within a growing organisation.

The position offers the opportunity to work closely with leadership, cross-functional teams, and clients, while helping shape scalable and efficient ways of working across the MI function.

Why this matters for you

This role is ideal for someone looking to take on broad operational responsibility and contribute beyond day-to- day delivery.

In this role, you will:

• Provide strategic oversight of sponsor accounts with end-to-end accountability for Medical Information activities
• Drive team growth, capability development, and operational excellence
• Lead process improvements, SOP development, and technology-enabled solutions
• Partner with internal stakeholders during program planning and business discussions
• Apply your Pharmacovigilance (PV) experience to support effective collaboration across MI and PV activities

What you will own

Service delivery and client ownership

• Lead end-to-end MI delivery for assigned sponsor clients, ensuring adherence to contractual SLAs, applicable regulations, and global guidance
• Act as the primary point of accountability for quality, timelines, and compliance across your portfolio
• Handle and oversee medical enquiries from HCPs, patients, consumers, and other stakeholders across phone, email, and other channels, including non-IST coverage where required
• Own quality control of MI responses, escalations, and adverse event and product complaint handoffs to PV and Quality

Function building and team leadership

• Lead and mentor a growing MI team, with a clear mandate to scale and shape the function
• Recruit, onboard, coach, and develop MI Associates and Specialists
• Identify skill gaps, design training plans, and elevate the technical and scientific capability of the team
• Oversee workload distribution and proactively escalate risks before they impact quality or delivery

Content, systems, and continuous improvement

• Author and review SOPs, work instructions, and controlled documents for the MI function
• Lead development and lifecycle management of Standard Response Documents, FAQs, and global content libraries
• Oversee MI project setup, database configuration, validation, and onboarding for new client engagements
• Contribute to how we use technology, automation, and AI to make MI delivery faster and better, without compromising scientific rigour

Compliance, audits, and stakeholder engagement

• Represent the MI function during sponsor audits, regulatory inspections, and internal quality reviews
• Maintain a strong compliance posture across documentation, training, and CAPA
• Partner with PV, Quality, Regulatory, and Commercial teams internally, and with sponsor Medical Affairs counterparts externally

What we are looking for

Experience

• 15+ years in life sciences, with demonstrable depth in Medical Information, Pharmacovigilance, or a combination of both
• Prior MI management or MI team-lead exposure in a CRO, pharma, or biotech setting
• Track record of managing client relationships, SLAs, and audit readiness, ideally across multiple sponsors or therapy areas
• Experience handling medical enquiries across global markets and time zones

Skills and qualifications

• Life sciences or pharmacy degree; PharmD, MPharm, or equivalent advanced qualification preferred
• Strong working knowledge of MI and PV regulations, ICH guidelines, and global pharmacovigilance frameworks
• Comfortable authoring SOPs and controlled documentation
• Hands-on familiarity with MI databases and content management systems

How you operate

• You take ownership and do not wait to be told what to escalate
• You hold a quality bar without becoming a bottleneck
• You can coach a junior associate one hour and brief a sponsor lead the next
• You are curious about where the function is going, not just how it runs today

What we offer

• A clear and visible leadership career path, with continued growth opportunities as the function expands
• Direct exposure to leadership, clients, and the commercial side of the business
• The opportunity to build and shape a team rather than simply maintain one
• Competitive compensation, with structured performance reviews and growth planning
• Flexibility on working arrangements where the role permits