Providing Flexible Resourcing Solutions
The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes
Project Manager Scientific Affairs (80 to 100%) – 5350 LBD
Our client is a global provider of blood and plasma supplies and services is looking for Project Manager Scientific Affairs. This is a 24 months contract role with possible extension to a permanent role and based in, Switzerland (fully remote).
The successful candidate will have project management experience and background in the clinical evaluation process, with a track record of successfully managing the remediation of medical devices from MDD to MDR and/or IVDD to IVDR using various clinical evaluation strategies. The position will play a key role in supporting projects associated with new and/or legacy products. This position will typically work cross-functionally, driving the projects and in collaboration with the cross-functional teams to assure the successful execution of business goals.
This individual will need to stay current on the changing requirements and guidance from the Notified Bodies (NB), and the ideal candidate will have experience working through NB deficiencies to conclusion. Experience with NB audits would also be ideal.
This individual will have visibility to senior leaders and needs to be comfortable presenting project updates.
- Oversees and manages the Scientific Affairs Team schedule of deliverables, ensuring alignment with cross-functional partners and compliance to regulations and applicable procedures.
- Represents the Scientific Affairs team on Governance and core teams, working closely with Core Team Leads on timelines and Scientific Affairs needs.
- Communicates with stakeholders and obtains stakeholder alignment to ensure business objectives are met
- Contributes to the strategic approach for the team’s clinical evaluations with consideration of the portfolio-level view of other strategic approaches and NB feedback.
- Manages vendors that are contracted to support the Scientific Affairs Team’s body of work.
- Serves as the liaison to other functions and groups as needed.
- Provides the overall needs and schedule driving post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) data collection activities.
- Oversees updates to team templates and processes, ensuring team alignment and updated training as needed
- Ability to travel up to 25% domestically and internationally.
Qualifications (minimum requirements):
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Bachelors degree required with 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
- Excellent English language skills; French, German or other EU language is a plus
- Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
- Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
- Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, engineering, statistics, medical science, or other related medical/scientific field)
- Direct experience authoring clinical evaluation documents, including: PMCF/PMPF Plans, PMCF/PMPF Reports, Clinical Evaluation Plans/Performance Evaluation Plans, Clinical Evaluation Reports/Performance Evaluation Reports
- Direct experience with medical and/or scientific writing within a medical device industry or related industry
- Proficient knowledge of transfusion medicine/haematology
- Familiarity with international regulatory requirements and knowledge of relevant standards (e.g. ISO 14155, ISO 14971, MedDev 2.7.1 rev 4, EU MDR, applicable MDCG)
- Working knowledge of various writing style guidelines (e.g., AMA) and current publication practices and guidelines (ICMJE)
- Experience planning and executing internet literature searches using databases such as PubMed
- Working knowledge of biostatistics
- Experience working with Galaxy, Endnote or other literature repository and citation management tools
- Relevant experience within the medical device industry