Associate / Medical Director Cover Letter

Please consider me for the associate / medical director opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for scientific input and contribute to the creation of relevant clinical documents, such as Investigators' Brochures, clinical trial protocols, Clinical Study Reports (CSRs), or regulatory submissions to ensure high quality and accuracy.

Please consider my qualifications and experience:

• Previous UM/appeals experience preferred
• Internal Medicine, Emergency Medicine, and/or Family Practice, Neurology or Radiology Board Certification preferred
• Demonstrated experience within pharma and understanding of MLR process
• Substantial knowledge of clinical medicine, preferably across a broad range of conditions
• Solid experience in content development, clinical writing, and familiarity with industry standards (e.g., AMA style)
• Self-motivated, positive attitude, and very high energy with excellent teamwork skills
• Advanced skill level in Microsoft Word, PowerPoint & Outlook
• Experience being a team supervisor or managing a contract staff

I would like to submit my application for the associate / medical director opening. Please accept this letter and the attached resume.

Previously, I was responsible for medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRF design, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting.

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:

• Takes an end-to-end view of the supply chain to understand upstream/ downstream impact of actions taken at any node
• The engineer applies the business competencies in a manner that challenges and enhances overall operational effectiveness and routinely provides feedback and coaching to team members and collaborators on these skills
• Provide technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents
• High customer and external industry insight
• Very strong and demonstrable presentation, communication and influencing skills that can impact at all levels
• Strong leadership, motivated to develop, guide and reward high performance teams
• Good oral and written skills in both Chinese and English
• Master Public Health is preferred in addition to MD / DO

I am excited to be applying for the position of associate / medical director. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for strategic and scientific input into regulatory documents for new drug and clinical trial application in China in close collaboration with regulatory team.

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

• Medical qualification (MD) with specialty training (rheumatology or internal medicine preferred)
• Experience in clinical practice in relevant discipline preferred
• Experience in the pharmaceutical industry in clinical development in Phase 2 and 3 (rheumatology or immunology preferred)
• Doctor of Medicine or Osteopathy (M.D./D.O.)
• A physician in good standing with Medicare, Medicaid, and other federal and state health insurance programs, not excluded from participation in Medicare, Medicaid or any other federal or state health insurance program
• Knowledge and experience of legal and regulatory requirements related to the Pharmaceutical/Medical Device industries
• Outstanding organization skills with close attention to detail
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes

In response to your job posting for associate / medical director, I am including this letter and my resume for your review.

In my previous role, I was responsible for active medical and scientific contributions to a cross-functional clinical team developing and providing support for Esketamine Clinical development program, providing input to the clinical development plan, works on the development of the clinical trial protocol(s), clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings.

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:

• Help to develop communication platform (or scientific platform for medical education) that will serve as an internal content roadmap and foundation for communications
• Demonstrated high level of competency with Customer Relationship Management (CRM) Systems, SharePoint, IT systems and MS Office applications
• Handle Strategic planning, guidance and implementation of programs, including clinical development programs, to support and drive the development of new claims and new products for existing and new OTC brands
• Review and approve global advertising copies and promotional copies from a Medical perspective
• Develop responses to Regulatory Authorities and ensure timely and accurate Medical submissions to Health Authorities
• Build strong relationships with key opinion leaders while working with emerging scientific discovery to keep the company informed of and ahead of the most recently published literature in various categories
• Maintain awareness and involvement in understanding scientific category dynamics including different classes of drugs associated with the category, understanding the mechanisms of action, PK/PD profiles, safety and efficacy dimensions unique profile characteristics to contribute to the strategic planning and development in support of existing and new brands
• Ensure compliance with both the letter and spirit of all laws and regulations

I would like to submit my application for the associate / medical director opening. Please accept this letter and the attached resume.

Previously, I was responsible for scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), biomarker strategy, clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).

Please consider my qualifications and experience:

• In-line and pipeline product knowledge of the competitive landscape, clinical practice trends and treatment guideline evolution
• Experience analyzing commercial potential of and prioritizing university-based inventions
• Experience managing IP matters, including documentation in support of patent applications
• Excellent interpersonal, oral, and written communications and analytical skills
• Experience managing small- to mid-sized teams
• Experience in supporting the education of research scientists on the patent process
• Experience with information and knowledge of relational databases
• Experience with therapeutic development