Clinical Supply Chain Cover Letter

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

In the previous role, I was responsible for drug information to physicians, nurses and other health care professionals, as related to clinical investigational trial drugs;.

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

• Experience in a clinical supply chain environment within the pharmaceutical industry is highly preferred
• Experience in manufacturing, pilot plant experience, experience in technical transfers, in product lifecycle management can be also very relevant
• Experience with Werum PAS|X in the areas of MBR Editing, Characteristics and Order Network processing, Equipment Management, Finite Scheduling and Level 2 integration
• Experience with Pi
• Experience with data acquisition tools, such as Spotfire
• Experience with IS management tools, such as ISM
• Experience with Analytical Method execution and documentation
• Experience in Drug Substance and Cell Bank processing

I would like to submit my application for the clinical supply chain opening. Please accept this letter and the attached resume.

Previously, I was responsible for expertise and oversight on the development, review, approval, and follow-through of investigational new drug application technical sections of regulatory submissions as they relate to shipping, and distribution.

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:

• Education in chemical engineering, chemistry, or other relevant fields
• Completion of formal supervision principles or leadership education
• Knowledge of inventory control software such as Pathways Materials Management
• Should have a strong commitment to teaching excellence
• Experienced with design and/or management of Interactive Response Technology for the management of drug supplies
• Working as a key member of the PharmSci Project Team, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives
• The SCL provides innovative solutions to clinical drug supply production and distribution and creates and implements these solutions through utilization of vendor resources for all aspects of supply
• The SCL utilizes the knowledge and skill of in-house vendor points of contact to drive successful execution of unit operations

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

In the previous role, I was responsible for expertise and oversight on the development, review, approval, and follow-through of investigational new drug application technical sections of regulatory submissions as they relate to packaging, labeling, shipping, and distribution of clinical and commercial supplies.

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:

• Thorough scientific understanding of filling, label/packaging and associated regulations
• Excellent oral and written communication skills to include presentations in support of training on new procedures
• Mastery of with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software preferred
• Experience leading diverse, direct and matrixed teams
• Excellent computer skills, including high proficiency in Microsoft Excel
• Possesses an understanding of and has expertise in the field of clinical supply chain management, including experiences in managing complex clinical trials with regards to their supply chain
• Very good knowledge of GMP regulation, training and process management project management
• Effective in communication with peers and management

I would like to submit my application for the clinical supply chain opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for support to CSSM and Global Product Development (GPD) on the development of clinical study protocols and DAI, specifically providing clinical pharmacy guidance with the handling, preparation and administration of investigational products at clinical sites.

Please consider my qualifications and experience:

• Certified in Project Management is preferred
• Excellent computer skills, including high proficiency in Microsoft Suite including Excel, Word and MS Project the Office 365 environment
• Clinical/scientific research, medical devices/pharmaceutical clinical trials and device distribution experience preferred
• Process Excellence, FPX or PMP certification is preferred
• Experience in clinical supply chain (CSC) or commercial function experience such as planning, manufacturing, or logistics is preferred
• Work experience in a GXP environment is preferred
• Demonstrated knowledge of enterprise systems and tools to manage supply chain – SAP, sharepoint, data warehouses, quality systems is preferred
• Knowledge or experience in regulated industry is preferred

I submit this application to express my sincere interest in the clinical supply chain position.

Previously, I was responsible for direct management, mentoring and ongoing coaching and development support for team of Clinical Supply Chain Managers (CSCMs) and Drug Supply Coordinators (DSCs) in addition to day to day management of assigned personnel.

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:

• Management of investigational products at a clinical research unit or investigational drug pharmacy
• Management of multi-disciplinary teams that includes project management, negotiation, conflict management, and process improvement
• An understanding of manufacturing and distribution operations
• Experience managing supply chain logistics and international shipping
• Strong interpersonal skills along with excellent communication skills both written and verbal
• Relevant CMC management experience within pharmaceutical and medical device industry highly desirable
• Fluent knowledge of all stages of pharmaceutical drug product development and manufacturing, process validation, analytical operations, compliance and documentation
• Strong CMC regulatory experience