Manager, Pharmacy

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The role:
The Pharmacy Manager provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, Manufacturing and Control (CMC) activities associated with them.
* Read, ensure understanding and adhere to all assigned ICON /Client SOPs and working procedures.
* Prioritize and control the manufacturing and packaging, labelling and release of products. Organize the procurement, storage and distribution of Pharmaceutical Products.
* Provides expertise to ensure compliance with GMP procedures and that these procedures are optimized.
* Direct Sponsor interactions along with converting Sponsor supplied information and the protocol into suitable package plan for multi-national studies.
* Understands Directive 2001/20EC, FDA and ICH Regulations on GMP and GCP, PIC/S
* Applies Good Manufacturing Principles in all areas of responsibility
* Recognize and exemplify ICON's values, which center around our commitment to People, Clients and Performance.
* As a Manager, the employee is encouraged to recognize the importance of and build a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Maintain confidentiality of management information as appropriate.
* Leads global pharmaceutical supply for all phases and pharmaceutical development activities ongoing at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of the client.
* Manage and maintain document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the Manager.
* To liaise with study teams and other TMF Operations staff in order to fulfil job responsibilities and activities and to assist in providing mentorship to study teams for study file archiving activities.
* Provide mentorship to IMP management, supply strategies, supply demand planning and forecasting, dosing, dispensing and formulation considerations.
* Advise, prepare and review study specific procedures for IP supply activities.
* Generation of Pharmacy Manuals to support use at clinical sites.
* Ability to enthusiastically direct/lead a team in the successful planning, execution and governance of a program of work, supply of medication and risk management activities.
* Lead projects in accordance with the contract. Actively seek any changes in scope and collaborate with Program Leadership to ensure timely completion of change orders.
* Effectively run the study budget to ensure financial targets are met. Collaborate with Finance to ensure accurate revenue recognition.
* Support the generation of new WPs and review of SOPs and engage with impacted departments across ICON to ensure tasks are assigned to appropriate functional leads.
* Triages queries to the GMP Subject Matter Expert group and ensures responses are answered to the best of the team's knowledge/experience within a reasonable timeframe.
* Participation in audits, inspection and capability meetings.
* Liaison with sponsors and ICON colleagues, e.g., Project Managers, Business Development and Contracts colleagues, with regard to new business proposals, costings and awards, including attendance at Bid Defense Meetings.
* Establish and maintain Technical Agreements in partnership with other IMP/GMP taskforce members.
* Lead all aspects of labelling, packaging and distribution activities of CMO including labelling / packaging records and distribution plans. Recall, returns and destruction activities, as appropriate.
* Coordinate the procurement of marketed drug product, such as comparators performed by an approved vendor and ensuring together with GRA / SSU that all study specific regulatory requirements are met.
* Perform Batch Record Review and Approval, as applicable.
* Gap analysis of processes relating to pharmaceutical supplies for applicable project teams.

You will need:
* Degree in Biological Sciences or local equivalent.
* Due to the nature of this role, a Pharmacy Degree (PharmD) is preferred.
* Significant experience i.e. pharmaceutical, biologics, medical device with regulatory experience in the local environment (Europe).
* Experience with all potential formulation variations.
* Provide advice on formulation/drug substance queries for projects/RFPs.
* Experience in consulting, supporting business development activities and people management an asset.

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.