CASE STUDY - LS LAW
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Standardising online-content compliance across 121 markets — one source of truth

 

Learn how we built a global compliance guide standardising the online-content rules, gated access, HCP confirmation, server localisation, language requirements and country-specific approvals, across 121 markets in Europe, CIS, the Middle East, Africa and Asia-Pacific. Built for the in-house teams who run online content programmes for a global pharma and need a working starting point rather than a 121-country research project.


 
 

Background

 

The client is a Japan-based global specialty pharmaceutical company — circa $3 billion in revenue, around 7,000 employees worldwide, listed on the Tokyo Stock Exchange — with a fully integrated international biopharma business that has grown from its Japanese base into commercial reach across Europe, the US and beyond. The international business covers EMEA and LATAM with around £350m of regional revenue, around 700 staff and an explicit strategic ambition to double revenue by mid-decade. Within that footprint, the Rare Disease Business Unit holds direct legal responsibility across the Northern Cluster and CEE, supports product launches and operates in a complex regulatory environment.

When the substantive Head of Legal for the Rare Disease Business Unit (EMEA) went on an unexpected leave of absence with an unknown return date, the client needed interim cover at Head of Legal level — not just additional capacity, but the leadership of an in-region legal team of three legal professionals, a seat on the SVP General Counsel & Chief Compliance Officer's leadership team, cross-functional collaboration with the Head of Compliance, the Head of Legal for Established Medicines, the Data Protection Officer, the SVP for the Rare Disease Business Unit and the EVP for Strategy. The role had to be filled at speed: a fast-paced, growth-oriented business does not pause for a procurement cycle.

 

 

 
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The LS Law Approach

 

Three connected workstreams: leadership cover, team continuity, clean handover. LS Law had been providing additional legal support into the Rare Disease Business Unit's legal team for some time prior to the absence — predominantly contracting-led capacity to free the existing legal team for other priorities, with Wendy Lloyd-Goodwin as the dedicated point of contact and account manager. That established working relationship meant that when the absence arose, we could scale up rapidly into the leadership seat without a fresh procurement cycle, fresh diligence, or fresh onboarding under stress.

Leadership-level cover at speed. A senior LS Law consultant with the EMEA pharma seniority required for the role stepped into the Head of Legal seat — leading the in-region Rare Disease Business Unit legal team, holding the seat on the SVP General Counsel & Chief Compliance Officer's leadership team, and providing strategic-level legal support to the business through the absence rather than triaging it.

Team continuity and cross-functional liaison. Direct line management of the three legal professionals across the clusters. Active collaboration with the Head of Compliance, the Head of Legal for Established Medicines, the Data Protection Officer, the SVP for the Rare Disease Business Unit and the EVP for Strategy — keeping the legal function plugged into the rest of the business through the leave period.

Discipline for the handover back. Maintained matter list, decision log and contracting tracker throughout the cover period — so when the substantive Head of Legal returned, the position handed back was current, well-documented and immediately usable, rather than a backlog the returning lawyer would have to dig out of.

The role profile we covered. Head of Legal — Rare Disease Business Unit, EMEA. The interim cover stepped into the role at the seniority and scope the substantive position required — leadership of the in-region legal team and direct legal responsibility for two regional clusters. Team leadership: build, lead and develop a legal team of three legal professionals across the regional clusters, supporting product launches and navigating a complex regulatory environment. Direct cluster responsibility: direct legal responsibility for the Northern Cluster and CEE for the Rare Disease Business Unit — the day-to-day legal seat for two regional groupings. Leadership-team membership: active member of the SVP General Counsel & Chief Compliance Officer's leadership team, contributing to the strategic development of the Legal Function and Team. Cross-functional collaboration: close collaboration with the Head of Compliance, the Head of Legal for Established Medicines, the Data Protection Officer, the SVP for the Rare Disease Business Unit and the EVP for Strategy. Risk and governance: active role in mitigating legal and compliance risks for the organisation — safeguarding the company's assets and reputation while assuring compliance with applicable laws and regulatory requirements. Substantive legal areas: hands-on across competition law, anti-bribery laws, access and reimbursement (including early-access schemes), pharmaceutical advertising law, regulatory laws (including regulatory data protection), IP and clinical trials.

Why this engagement could happen at speed — an existing relationship, scaled up. Procurement cycles do not pause for an unexpected leave of absence. Because LS Law already held an active fractional support engagement with the Rare Disease Business Unit's legal team — with established account management, agreed working practices, conflict checks and confidentiality controls already in place under signed terms — the client could move from 'our Head of Legal is suddenly unavailable' to 'leadership cover in the seat' without standing up a new vendor relationship under stress. That is the structural advantage of having a senior fractional partner already in the building when something unexpected happens.

 

 

The Outcome

 

Continuous operation through the absence — and a clean handover back. The legal function continued to operate at full capacity throughout the absence. The in-region team was led, cross-functional governance was maintained, business support continued at the level the Rare Disease Business Unit required, and the substantive Head of Legal returned to a function in good order — current, well-documented and immediately usable — rather than to a stretched team and a backlog to dig out of.

From a sudden absence of legal leadership to continuous operation at the senior level the role required — without a procurement cycle, without a backlog, without the team running on autopilot. Interim Head of Legal cover stepped in at speed by scaling up an existing fractional engagement — preserving team leadership, cross-functional collaboration and strategic-level business support throughout the absence, with structured continuity discipline that delivered a clean handover back to the substantive lawyer on return.

3 in-region legal professionals managed. 2 regional clusters direct (North + CEE). 1 leadership-team seat held continuously. Day one — scaled up from existing fractional engagement.

 

 

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