Director, Medical Affairs Cover Letter

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

In my previous role, I was responsible for medical review and/or sign-off for documents such as clinical trial protocols, investigator brochures, clinical study reports, and regulatory documents as part of cross functional team.

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

• Experience in clinical research, planning and implementing clinical study (protocols) including GCP knowledge statistics and study design is a positive
• Being part of a global team means that whilst physical location maybe somewhat flexible, frequent attendance of team meetings and time spend at the HQ in Switzerland is key and contractual engagement takes place in Switzerland
• Applicable therapeutic experience
• Job location to at U.S. corporate offices in Lake Forest, IL
• Organizes thoughts and presents content clearly selecting communication vehicles and venues most appropriate to meeting the business needs
• Maintains a positive and situational appropriate demeanor with internal and external customers
• Communicates relevant information to appropriate persons/stakeholders in a timely manner
• Demonstrates effective listening skills - active, clarifies, quantifies, and gets "buy-in"

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

In the previous role, I was responsible for the medical monitoring function as needed for trials, including protocol development, medical oversight ongoing clinical studies, management of potential safety issues, contributing to statistical analysis planning, providing medical interpretation of clinical trial data (both safety and efficacy).

Please consider my qualifications and experience:

• Trained Medical Practitioner
• Experience of setting, balancing and managing a budget to target
• Detailed knowledge of Health Canada regulations and guidelines, industry codes of practice/standards and standard operating procedures, and experience of their implementation within the business environment
• Principles and practice of medical affairs including clinical trial design, management, analysis and reporting, including GCP
• Knowledge MS therapeutic area, including solid relationships with neurology/MS key opinion leaders preferred
• Knowledge of the structure and management of the Canadian health system
• Excellent command of English both written and oral and good IT skills
• Leads teams

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

In my previous role, I was responsible for medical expertise and guidance during the development of clinical trial documents (for example but not limited to: clinical trial protocols, Case Report Forms (CRFs), Investigator Brochures (IBs), imaging manuals).

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

• Demonstrates wide range of acquired skills as head-office medical affairs team member, with both global and US remit
• Demonstrates strong written, interpersonal, and exceptional verbal communication skills
• Ensures that all medical affairs activities in support of the product adhere to all relevant industry regulations and guidelines, such as OIG and The Company’s Code of Business Conduct and Ethics
• Understanding of government/industry guidelines and U.S. healthcare landscape (managed markets, emergence of evidence based medicine, current regulatory environment, ) including, but not limited to, the Sunshine Act
• MD, PharmD, or PhD in Health Sciences preferred
• Excellent written and oral communication skills, particularly strong formal presentation skills
• Medically qualified doctor (ideally in immunology, vaccinology, infectious diseases, public health and/or epidemiology)
• Recognised experience and expertise in medical affairs roles in the UK pharmaceutical industry

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

In my previous role, I was responsible for medical review of all clinical trial protocols including investigator initiated trials, with attention to safety oversight and reporting to global regulatory agencies and investigators.

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:

• Assist in strategic management of investigator initiated studies (IIS)
• Manage the MSL team to support R&D and the clinical operations team with all US clinical studies
• Collaborate with Clinical Operations to identify potential research sites
• Collaborate with Patient & Professional Advocacy to provide medical support
• Communicate to investigators and KOLs regarding study progress, results, and provide any additional on-site assistance to facilitate study progress
• Provide strategic input, interact, collaborate and ensure alignment with Medical Affairs objectives
• Interact and collaborate with Legal/Compliance, Human Resources and Finance Departments to ensure an effective, compliant and strategically focused US MSL Team
• Ensure compliance with legal and regulatory guidelines to emphasize and provide medical and scientific accuracy and fair balance in all MSL communications

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

In my previous role, I was responsible for deep medical insights in disease biology, product attributes, and clinical trial design into the development of Product Team strategic options and Global Product Strategy.

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

• Advanced clinical medical/ experience / medical practice
• Proven leadership and leadership peer interaction
• International team management
• Medical Society/ medico-political experience is a strong recommendation
• High mobility to interact with physicians across the region
• US Board Certified Rheumatologist preferred or strong international or regional experience
• Build and lead the US Medical Affairs organization, setting the strategic direction of US Medical Affairs in alignment with the Global Medical Affairs objectives
• Build partnerships and relationships with the scientific and medical community