Rima Yousef Email & Phone Number

Auckland, Nz

New Zealand

Auckland, New Zealand

Auckland, New Zealand

- Production of competitive tender submissions, working closely with the Bid Manager, Graphic Designer and other key personnel. Activities include: -background research of client requirements and policy analysis -analysis of contract documents -site visits -workshop facilitation- Assist with the collation and maintenance of project information, including progress photos, project story boards & client/stakeholder feedback.- Information management activities, ensuring tender and project information is appropriately stored in the corporate systems.- Post tender submission reviews, reviewing writing, presentation and delivery of tenders to identify opportunities for improvements. - Development of capture strategy & implementation of capture initiatives- Write attributes & where others contribute ensure that the content is relevant & hits the mark to ensure high quality content is submitted.- Qualification and management through to production and presentation of quality tenders and presentations.- Assist the Bid Manager and Project/Contract Manager as required in the information handover and project delivery start-up phase of the tender cycle- Work with other key areas of the business to identify opportunities to improve approach to tendering and tender submission content.- Coordinate and liaise with all stakeholders’ during pre-tender and tender stage.- All appropriate stakeholders are given the opportunity to contribute and review prior to submission.- Develop and maintain a wider array of internal and external networks to meet organisational objectives. Remove barriers to create teamwork amongst diverse groups.- Development of robust project plans for development and delivery of tender opportunities working to tight deadlines.- Management of internal and external stakeholder interfaces. - Identification and minimization of business risks and compliance issues.

- Establishment of EU/ROW and US licenses into current solutions ready for migration to the new Documentation Management System- Ensure input of regulatory data and documentation from customers and the Regulatory team is generated into tracking systems- Ensure Library is up to date with all relevant documentation sent or received- Ensure Document Management Database is reflective of tracking solution entries- Entry of Company Contracts including PIPA registrations and milestones from PIPA Agreements are captured and maintained- Ensure that invoices to customers in relation to triggered milestones, Consultancy expenses, Health authority fees & commission are raised/issued and tracked- On-going maintenance and administration of Database systems post go-live of the Documentation Management Solution- Data cleansing of existing Douglas systems- Establishment of common folder structure and naming conventions for Regulatory information in preparation for Data migration and the document management system- Transfer of legacy data for current registrations to the Documentation Management System - Transfer of Library legacy data to the Document Management System- Conduct user engagement and end user training of the Documentation Management System- Understanding of the different registration pathways and processes for different territories to ensure Database is set up correctly - Ensuring dossier templates are current at all times and in accordance with health authority requirements- Working with project lead to ensure license renewals in a timely manner- Ensuring correct procedure types are followed and documented for each territory - Working alongside & assisting the Project Lead with the process analysis for the data and document migration to ensure the correct decision is made for the business and the right metadata is migrated - Assisting the PM with writing of the business process- Setting up meetings and calls with consultants and the supplier

- Preparing GMP compliant documents for use in the laboratory (including Analytical Procedures (APs) and SOPs) using the ISO 9000 standards.- Reviewing documents against the European, United States and British pharmacopoeias.- Liaising with departments for initiation, execution and application of changes to documents.- Checking and signing off Raw Material, Secondary Standard APs and Solution Sheets.- Involvement in the LIMS project to strive to a lean/paperless laboratory information system and to prepare documentation for the project- Make documentation efficient and consistent Ensure updates of all related documents are completed within the same time frame and in a consistent format- Generating CRNs for changes to laboratory documents and implementing them.- Test method preparation for LIMS project- AP break down into new documents and procedures - Creating new specifications- Daily use of SAP and Starlims applications- Training of casuals and temps on how to create new documents and extract existing ones for LIMS phase 1 preparation- Weekly meetings to communicate work completed and work planned- Whilst working on the LIMS project, I was leading a team of three within the project, streaming work through to them and assigning tasks and tracking completion date, whilst working on my own project within the project. - Providing my manager with regular updates on work completed by my team. - Planning work in accordance with timelines and deadlines- Communicating and tracking work planned and completed

- Systemic use of Newport and Cortellis databases to identify opportunities - Communication with in-market business Development experts to identify generic opportunities - Development of Gate 2 financial models as part of the Gate 2 presentation - Present at pipeline committee meetings- Minute taking and agenda preparation for NPD update meetings, pipeline committee meetings and gatekeepers meetings- Assist R&D director in consolidating NPD monthly operational report - Assist/support project managers in preparing gate 3+ reports and presentations required. - Ensure business cases at gate meetings are signed and filed. - Co-ordinate and manage templates and data population for preparation of weekly resource meetings.- Support R&D director with files/documents for conferences/meetings such as CPhI- Literature review and patent scoping

- Competently carry out stability testing as needed e.g. Related substances, Assays, Dissolution- Competently use HPLC, Karl Fischer, GC, Glove box micro balance, IR and UV systems- Daily calibration of water system, micro and analytical balances, pH meter and capsule hardness tester - Have completed large quantities of stability testing single handedly - Training of staff on how to perform testing and use of chromatographic and spectroscopic instruments to level 3 (competent) - Carry out validation studies for solution stability - Review SOPs and write new ones - Reduction of expenditure on non-value tasks, getting tasks right the first time- Reduce waste and plan work to increase team efficiency- Working independently and plan personal workload within requirements of weekly and monthly targets- Assigned work completed on time and to the standard required- Assisting team lead with long term capacity planning- Training and supervision of junior and other team members - Maintain high level of compliance and productivity with no major or critical findings in work performed, found during audits- Reporting deficiencies in products and then reporting back to the lead- Laboratory investigations initiated and carried out in a compliant and timely manner- Writing investigation reports for own work and other teams where applicable- Set up and maintain stability programs including protocol preparation, sample placement, sample drawn down and receipt, issue of paper work- Prepare and check data tables for regulatory submission- Respond to requests in a timely manner proving relevant data and reports - Advanced communication of delays to planned work and project deadlines- Liaise with project managers and regulatory affairs in preparation for approvals of protocols for additional team activities such as: dissolution profile testing, freeze/thaw studies, photo-stability, temperature excursion studies, innovator comparative testing etc.