Clinical Supplies Cover Letter

Please consider me for the clinical supplies opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for project-specific oversight of Project Coordinators, Clinical Trial Assistants, Clinical Research Associates and other team members;.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Generates project specific master documents
• Knowledge cGMPs and relevant FDA Regulations
• Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, ) to determine and anticipate the impact on supply forecasts and supply plans
• Provide input to IRT specification design
• Understanding of Research and Development within the biopharmaceutical industry
• Internal stakeholder management, data/information management, category management, process redesign and continuous improvement expertise, project management and performance measurement skills
• Procurement process knowledge, contract management, financial analysis, market analysis, supplier analysis, supplier diversity, supplier management, technology utilization, strategic planning and integrated supply chain experience
• BSc/BA or equivalent in business or sciences

In response to your job posting for clinical supplies, I am including this letter and my resume for your review.

In my previous role, I was responsible for vendor management, inclusive of ensuring key Clinical Trial Supplies deliver ables are met and financial parameters of contracts are upheld.

My experience is an excellent fit for the list of requirements in this job:

• Specification review and approval
• Clear understanding of related SOPs, cGMPs and GLPs and as necessary to accomplish daily tasks
• Pharmaceutical GMP
• Demonstrated leadership, incl
• Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/ groups at all levels
• Experience managing contract packaging and labeling organizations (strongly preferred)
• Demonstrable experience in Interactive Response Technology (IRT) or clinical supplies
• Experience in working help desk or customer support role

In response to your job posting for clinical supplies, I am including this letter and my resume for your review.

In the previous role, I was responsible for administrative and project support to the Clinical Research Team within a busy and complex portfolio of clinical studies across all trial stages.

Please consider my qualifications and experience:

• Teamwork especially in a matrix management organisation
• Demonstrated competency with software tools used for internal and external communications such as the Microsoft Office Suite, including MS PowerPoint, SalesForce.com, or other CRM software
• Sales, communication and presentation skills in English and French
• Self-motivated and goal focused to achieve results
• Sales, communication and presentation skills in English
• Experience working with LIMS systems, validated document repositories (MIDAS or Documentum), and Change Management software (Trackwise)
• Understanding of applicable regulations and guidelines governing clinical supply manufacture and release (CFR, ICH)
• Daily supervision of direct reports – includes direction of daily activities as necessary, resolution of problems/issues with QA and internal and external clients

In response to your job posting for clinical supplies, I am including this letter and my resume for your review.

In the previous role, I was responsible for assistance to the Protocol CSPM to ensure timelines for clinical supply needs per project are met.

My experience is an excellent fit for the list of requirements in this job:

• Prepare associate performance reviews for assigned associates
• Provide performance reviews in both oral and written form to associates
• Review and approve Deviation Reports as assigned
• Participate in Packaging Investigations as assigned
• Train and mentor associates as needed
• Participate in internal department or system audits
• Conduct packaging audits (on-the-floor)
• Batch record review and approval

In response to your job posting for clinical supplies, I am including this letter and my resume for your review.

Previously, I was responsible for input and coordinate the delivery of clinical trial supplies in collaboration with clinical supply team.

Please consider my qualifications and experience:

• Understanding of the development process and clinical supplies
• Demonstrates fundamental knowledge of supply chain computer systems
• Works with Clinical Research & Operations Project Management to forecast drug product requirements, study specific clinical supply costs, and timelines
• Works with Pharmaceutical Development to deliver drug products for packaging, assessing product dating, storage conditions, primary components, analytical testing needs, and retain quantities
• Works in collaboration with the Clinical team to develop the clinical supplies section for protocols, develop the clinical supplies plan and create labels
• Creates packaging designs and generates label copies in accordance with study design requirements and obtains internal approvals
• Manages the vendor selection process
• Requests quotes and reviews/approves proposals