Hub Submissions Manager at Pfizer (FWA/MAGHREB SME / Lead)
Lead a team of three submission managers supporting the French West Africa and MAGHREB regions of Africa/Middle East in all submissions from NCE to lifecycle and responses.
Participation in the delivery of project specific Pfizer paper and electronic submissions, including creation and co-ordination of publishing strategies around the unique requirements of each submission, and management of product delivery to regulatory agencies
Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied.
Maintain awareness of multiple dossier format and publishing requirements
Lead/participate on global and local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions
Liaise with the submission team managers to effectively forecast and manage project specific resources utilising flexible resourcing
Perform archiving and quality control checks adhering to departmental procedures
Includes 6 month secondment into Inhalation Dosage Manufacturing to streamline processes and interactions between the groups
All tasks undertaken within Clinical Supplies Manufacturing Inventory and Sourcing involve a sound knowledge and understanding of GMP processes, and the paramount importance of completing GMP documentation with 100% accuracy at all times and the absolute importance of individual or electronic checks.
Maintain a working knowledge of multiple electronic inventory systems
Lead/Participate in Continuous Improvement projects across multiple lines and countries
Create/Provide feedback for Global and Local Standard Operating Procedures under remediation
Adherence to strict GMP guidelines
Material Sub-Division, including hazardous materials up to OEB 5 class compounds.
Reconciliation of stock, appropriately label and despatch materials including pick, pack and shipment of materials to other Pfizer sites, clinical sites, preferred vendors and other locations.
Receipt of packaging components, raw materials, intermediates, bulk and packaged tablets and Active Pharmaceutical Ingredients for clinical and developmental use within the GMP areas of Clinical Supplies Manufacturing
Maintain the highest standards of good housekeeping within the warehouse environment in accordance with cGMP
I joined the Institute of Financial Services (IFS) in the Student/Customer Services team.
Due to this being a regulatory body (qualification mandatory for Mortgage/Financial Advisors) the roles and responsibilities were segregated into teams and my team dealt with the call centre which involved queries, new registrations, examination entries and sales.
During my time at the Institute of Chartered Secretaries and Administrators (ICSA), I started as an Assistant Administrator with responsibility for the ‘Company Secretary’ magazine subscriptions.
Following a strategic alliance with the Institute of Administrative Management (IAM), I was promoted to Administrator dealing with all aspects of the Membership of the IAM. After a short while I was promoted to Senior Administrator and led a team of four with responsibility for the Membership and Student Services of the IAM which included but was not exclusive to:
Queries and issue resolution, student registrations, payment processing, examination entries, examination invigilation at the London test centres, producing examination results transcripts, producing qualification and membership certificates, presenting awards at graduation ceremonies, membership renewals, sales (additional training material, membership plaques/ties etc) Member and Fellow nominations.
Due to a large majority of the Student/Member body being overseas, most communication was via telephone or email, with just a few face to face meetings.
I also dealt with the ICSA’s own administrative student organisation, the Institute of Business Administration and Management (IBAM) and it’s membership organisation, the Institute of Business Administration (IBA) both of these bodies had a very low membership rate, so I undertook similar tasks, but on a much smaller scale.
I joined the IAM after they separated from the ICSA and undertook the same roles and responsibilities as I had previously.
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