Senior Expert - Device Project Leader - Combination Product Portfolio 3 (f/m/d)

<p><b>Band</b></p>Level 4<p><br/> </p><p><b>Job Description Summary</b></p>With the increasing diversity of Novartis' portfolio, the need for driving our drug-device combination product portfolio is also increasing. As such, we are searching for a Senior Expert – Device Project Leader for joining our team in Schaftenau in the Portfolio &amp; Customer Center within Global Device and Packaging Development. <br/><br/>In the role of Senior Expert – Device Project Leader, you will be a vital part of the Portfolio &amp; Customer Center within the Global Device and Packaging Development (GDPD) team based in Schaftenau/AT. Your primary responsibility is to guide and manage cross-functional project teams both within and outside of the GDPD. This includes representing GDPD in the CMC sub-teams, leading relevant discussions, gaining support, and securing approval for project strategy and changes.<p><br/> </p><p><b>Job Description</b></p><p><b><span>Key Responsibilities:</span></b><span><span> </span></span><span><span> </span></span><br/><span><span>Your responsibilities include but are not limited to:</span></span><span> </span></p><ul><li><p><span><span>Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Lead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Plan, manage, and control project resources, schedules, and budgets. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Assess and negotiate internal &amp; external resource needs on an ongoing basis. Establish and </span><span>maintain</span><span> a high-quality Design History File for developments and LCM projects until transfer to manufacturing sites. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Contribute to the improvement of process and delivery technology approaches. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Evaluate suitable device technology to support different project phases. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Support internal and external audits on packaging and medical device related matters.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Assist</span><span> teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries.</span></span><span> </span></p></li></ul><p></p><p><b><span>Essential Requirements</span></b><span><span>: </span></span><span> </span></p><ul><li><p><span><span> </span></span><span><span>Master or PhD</span><span> (preferred) in natural science, engineering</span><span>,</span><span> </span><span>pharmaceutical field</span><span> or equivalent</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>M</span><span>inimum </span><span>2</span><span>-</span><span>4</span><span> years</span><span> of</span><span> experience in </span><span>the </span><span>pharmaceutical industry</span><span>, preferably</span><span> in </span><span>drug-device</span><span> </span><span>combination product </span><span>technical </span><span>development</span><span> </span><span>including</span><span> technical operations</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ability to work and lead a cross-functional team in a matrix environment</span></span><span> </span></p></li></ul><ul><li><p><span><span>Proven knowledge</span><span> and </span><span>track record</span><span> in </span><span>project and program planning and execution</span></span><span> </span></p></li></ul><ul><li><p><span><span>U</span><span>nderstanding and awareness of regulatory guidelines for </span><span>drug-device </span><span>combination product</span><span>s, including relevant ISOs and </span><span>current good manufacturing practice</span><span>s</span><span> (cGMP).</span></span><span> </span></p></li></ul><ul><li><p><span><span>Collaborative spirit, self-driven attitude, </span><span>high level</span><span> of learning agility</span><span>, </span><span>good </span><span>listen</span><span>ing skills</span><span>, strategic</span><span> thinker</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Fluent in English (oral and writing)</span><span>, German is beneficial</span></span><span> </span></p></li></ul><p><span><span> </span></span><br/><span><span>Why Novartis? </span></span><span><span> </span></span><br/><span><span>Our purpose is to reimagine medicine to improve and extend people’s lives and ou