- Bachelor's degree or equivalent in Science, Engineering, or a related field
- 10+ years of experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization).
- 7+ years of experience as a management consultant / project manager leading project teams in a matrixed, global environment, including those with complex technical, geographic, or regulatory elements.
- Experience in management consulting to the pharmaceutical or healthcare sector with international exposure, gained through pharmaceutical/ healthcare practice with reputable top-end full-service global consulting firms or boutique specialist consulting firms.
- Excellent knowledge of international regulations (ICH, EU GVP Modules, FDA, etc.)
- Operational experience in international pharmacovigilance, in-depth knowledge of PV processes and industry best practices in different PV area
Director, PV Strategy and Operations Excellence - Maidenhead, United Kingdom - CSL
Description
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Director, PV Strategy and Operations Excellence? The job is located in the King of Prussia or Maidenhead UK office. This is a hybrid position. You will report to the Senior Director, Head of GSPV Business Operations & Project Management.
Main Responsibilities and Accountabilities:
1. Support the SVP, Head of GSPV in creating enterprise level mid- to long-term strategy in all sub-functions of Pharmacovigilance (PV) including Innovation, Medical Safety, Safety Science such as signal detection, PV Operations and data analytics, PV Compliance, Affiliate management, Donor Safety oversight, to place CSL's Safety framework and outputs for patients and donors is achieved at the position against competitors.
2. You will support the SVP, Head of GSPV to create an oversight mechanism of the Safety Department's global operations at enterprise level to ensure excellence in operations. This includes the creation of a nuanced oversight framework and measurements, and their implementation.
3. Maintain constant awareness of GSPV our goals and priorities. Conduct and lead comprehensive assessments, develops tailored strategies, and provides applicable recommendations to support main challenges and opportunities such as, GSPV's 2030 business transformation plan.
4. You will, include any financial constraints; Improve trade-off decisions, and ensures successful program outcomes.
5. Develop comprehensive project plans that are anchored in the strategic goals, including scope, timelines, resource allocation, and budget, to ensure the execution of priority projects. Ensure there is a strategy for to leadership to provide assurance of execution according to pre-defined expectations.
6. Lead, influences, and mobilizes collective effort, without direct authority, transversal teams of subject matter experts and partners, encouraging collaboration, agreement, and accountability towards common goals.
7. Monitor project progress, identify issues, and implement mitigation strategies to keep programs on track and deliverables; ensure clear pathways for escalation are followed.
8. Use well established and novel program management methodologies and best practices to lead efficient project execution, ensuring quality, consistency, and adherence to project requirements.
REQUIREMENTS:
BENEFITS
Medical, Dental Vision
401K
Paid time Off
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Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.