Director/Senior Director - Medical Information

Soterius Life Sciences India Private LimitedOregon, United StatesRemoteFull-timePrincipal, 12–15+ yearsListed 3 hours ago

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About this role

# 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