Director Medical Cover Letter

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

In the previous role, I was responsible for input to regulatory strategy and leads clinical development discussions at regulatory interactions and clinical components of the submissions.

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:

• Doctor of Medicine, or Doctor of Osteopathy
• Possession of a current license to practice their profession in the State of Michigan
• Possession of an appropriate state prescribing license and federal Narcotics and Dangerous Drugs License (MD and DO only)
• Thorough knowledge of leadership and management principles, practices and methods
• Knowledge of electronic health record, preferably EPIC
• Recent experience practicing their profession
• Experience with a student health service
• Some knowledge of University and departmental policies and procedures

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

Previously, I was responsible for medical writing and editing expertise for various documents including those for clinical development and medical affairs (clinical study outlines, clinical protocols, amendments, reports, etc.), and for regulatory submission documents (IND applications, NDA, meeting packages, etc.).

Please consider my qualifications and experience:

• Previous experience with medical review work in a managed care environment preferred
• Experience with Medicare Part D preferred
• Publication planning and execution experience working within the pharmaceutical industry or publication agency
• Experience in an Administrative and/or Management role
• Demonstrate clinical and technical knowledge of medicine across an array of therapeutic areas, including oncology and immunotherapy
• Be able to translate high-science content for a broad range of HCP and HCC audiences at an expert level, providing guidance to an intuitive understanding
• Feel comfortable with the identification, assimilation, and interpretation of scientific insights, facts, market research, and other resources to collaborate in strategic planning and creative processes, to ascertain market landscape traits, and identify brand barriers/opportunities
• Prepare scientific and strategic analysis of data and research in collaboration with his/her team

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

In my previous role, I was responsible for input to regulatory strategy (or, in the role as Evidence lead, oversees regulatory strategy) and leads clinical development discussions at regulatory interactions and clinical components of the submissions.

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

• Management/leadership experience within the healthcare industry
• Experience using electronic medical records (EMR) software
• Utilize novel and creative methods to resolve clinical development problems independently
• Working knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and execution
• Experience in analysis of research data and publications
• Board certification or eligibility in Neurology or another relevant specialty area
• Active and unencumbered physician's license in Texas
• Experience with CMS regulations, NCQA, HEDIS

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

In the previous role, I was responsible for clinical expertise and technical excellence for asset development, clinical strategy, ensuring compliance with internal and external standards (regulatory authority requirements, stakehold requirements and quality standards).

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

• Proficient knowledge in regulatory science, post-market surveillance, clinical practices, risk management and quality management system requirements
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the development of clinical strategy and the design of study protocols
• Strong interpersonal communication and medical writing skills with demonstrated proficiency working effectively with technical staff from diverse backgrounds and cultures
• MD, PhD, PharmD or RN
• Analyze and synthesize complex information from multiple sources
• Communicate medical/technical information to a wide variety of audiences
• Work in a fast-paced, deadline-driven, team-oriented environment
• Efficiently prioritize multiple tasks and provide effective direction to others

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

In the previous role, I was responsible for insight from the Regulatory Planning & Execution (RPE) perspective into the Global Regulatory Affairs and Clinical Safety (GRACS) Digital Strategy development teams.

Please consider my qualifications and experience:

• The Medical Director for Pompe will represent the company and participate actively in select local, national and international meetings that pertain to Pompe Disease and/or Amicus’ Pompe Development Program
• Additional advanced management training or degrees preferred, MBA, MHA, PMP, MSCR
• Well-versed in regulatory compliance regarding medical affairs activities and clinical research
• Experience in orphan drugs and rare diseases is preferred
• Excellent medical and scientific credibility
• Experience in leading and guiding the development of a broad range of communications, including slides, articles, and peer-reviewed publications
• MBA, business or marketing experience preferred
• Knowledge of preclinical and clinical research methods and drug approval processes