Senior Project Manager

Temporary Assignment | Pharma / Biotech

Location: Zug, Switzerland (hybrid/onsite as required)

Contract: Temporary assignment (hiring on behalf of our client)

Function: Commercial Operations / Regulatory Operations

Therapeutic Area: Cardiology (rare disease)

Overview:

We are hiring on behalf of our pharmaceutical client for an experienced Senior Project Manager – MLR Operations to support a critical European launch phase. This is a hands-on, execution-focused role responsible for driving the Medical, Legal, and Regulatory (MLR) review process for launch and post‑launch materials.

The role will initially focus on Germany, establishing a scalable MLR operating model that will later be rolled out across additional European markets including France, Italy, Spain, the UK, and other EU countries. This temporary assignment is well suited to professionals who are comfortable operating in fast‑paced launch environments with high material volumes and tight timelines.

Key Responsibilities:

MLR Process Management (Launch Phase):

• Manage the end‑to‑end MLR review lifecycle for promotional and non‑promotional materials using Veeva or a comparable system
• Act as the central point of coordination for launch assets, prioritizing high‑impact materials in line with German and EU launch timelines
• Chair weekly MLR review and adjudication meetings, driving resolution of open issues and documenting final decisions
• Ensure timely implementation of MLR feedback by internal teams and external agencies, often within short turnaround windows

Localization and German Market Compliance:

• Oversee global‑to‑local adaptation of materials for Germany and other EU markets
• Coordinate with translation and localization vendors to ensure scientific accuracy and appropriate local tone
• Ensure compliance with German promotional regulations, including HWG and FSA‑Kodex
• Liaise directly with the German Information Officer (Informationsbeauftragter) to secure final approval prior to material use

European Roll‑Out and Scaling:

• Replicate and scale the MLR framework following the German launch to support additional European affiliates
• Develop a repeatable MLR launch toolkit and processes for future country launches
• Act as the primary point of contact for external creative and translation agencies, managing timelines, quality, and deliverables

Required Qualifications:

• Minimum of 5 years’ project management experience within the pharmaceutical or biotech industry
• Background in Commercial Operations, Regulatory Operations, or MLR environments
• Proven experience supporting a drug launch in Germany
• Strong understanding of launch‑phase urgency, volume, and complexity
• Advanced experience with Veeva Vault or similar MLR systems, including workflow management and approvals
• Native or bilingual German and fluent English
• Solid working knowledge of German promotional regulations (HWG) and EFPIA codes

Preferred Qualifications:

• Experience in Cardiology and/or Rare Disease or Orphan Drug launches
• Experience managing educational or risk management materials through regulatory review processes
• Project management certification such as PMP or PRINCE2

Key Competencies:

• Ability to influence and drive outcomes without formal authority
• Strong attention to detail and compliance‑focused mindset
• Resilience and adaptability in high‑pressure, fast‑moving launch environments