Medical Writing Cover Letter

I submit this application to express my sincere interest in the medical writing position.

In the previous role, I was responsible for support for Regulatory Medical Writing submission-related activities for cardiovascular compounds as well as Regulatory Medical Writing safety monitoring reports and submission activities for Established products.

Please consider my experience and qualifications for this position:

• Ph.D., Pharm.D., M.S., R.N., or R.Ph
• Led Process Development
• Experienced at building a team
• Demonstrated experience in collaborating cross functionally within a matrix environment
• Experience in Regulatory Affairs either via industry or education
• Working knowledge of current electronic document management systems and information technology
• Experience in working with collaborative, cross-functional teams, including project management experience, and managing internal and external resources, including contractors and consultants
• Graduate in the life sciences or related discipline (biology, pharmacy, medicine)

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

In my previous role, I was responsible for strategic guidance to teams regarding the flow of content and guidance(s) pertinent to clinical and regulatory documents including key regulatory response documents and strategic documents supporting major regulatory submissions.

Please consider my qualifications and experience:

• Knowledgeable of Good Clinical Practices, FDA regulations, ICH guidelines and the drug development process
• Experience with global clinical trials and regulatory submissions
• Experience managing the work of external and internal medical writers and submissions staff
• PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline is highly preferred
• Strong understanding of drug development, clinical study design, regulations (CFR, FDA, and ICH guidelines), and scientific principles
• Experience writing clinical protocols, clinical study reports, and eCTD summaries
• Strong command of English language, grammar, style, logical progression
• Experience and proficiency with document templates and proper version control

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

Previously, I was responsible for local medical input and support of Regulatory filing for clinical trial application, and China participation of global clinical study.

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

• Thorough understanding of citation databases such as PubMed
• Activities require expert technical skill (e.g., as defined by Drug Information Association Medical Writing Competency Model) including techniques of scientific writing and editing
• Technical expert on a number of document types
• Fluent in English and local language (spoken and written, to write CSR/regulatory documents in English/Japanese and to work in a global environment)
• Knowledge of preparing clinical part of CTD and relevant regulatory guidelines (global and Japan local)
• Advanced skills to search research articles and literatures both for English and local language sources
• Writing skills to complete scientific documents to meet the requirement of medical experts
• Good communication skills to clarify issues and discussion points in both English and local language

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

In the previous role, I was responsible for clear leadership and accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.

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

• Sufficient biomedical and biostatistics knowledge to interpret outcomes from clinical studies
• Coaching skills to train other project colleagues of writing logically in a persuasive manner
• PhD or MSc
• Assumes role of Lead Writer for compounds
• Provide support to the publication planning and external presentations for assigned study teams
• May participate in initiatives to improve medical writing templates, processes, and standards
• Expert user of MS Word, Excel, PowerPoint, email and a familiarity with the use of document templates
• Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology

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

In the previous role, I was responsible for strategic input on the interpretation and implementation of regulatory guidelines for the development of company-internal processes, templates and scientific content needed for the development of all clinical document types.

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:

• General understanding of the drug development process, clinical regulatory document types, the principles of GXP and ICH guidelines, and applicable standards
• Experience working across multiple disease areas and technical disciplines
• Experience writing US and/or EU regulatory documents preferred
• Experience working in a Medical Affairs role is preferred
• Advanced word processing skills in MS Word/Office
• Advanced PDF processing skills in Adobe Acrobat
• Proficient in document management systems and key publishing software
• Experience in working on clinical submission documents, clinical study reports, protocols, appendices, , and assembly of electronic submissions in compliance with technical editorial and format requirements