Medical Writer Cover Letter

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

In my previous role, I was responsible for medical review of promotional materials in conjunction with the Promotional Review Committee to ensure scientific accuracy, clinical relevance, and compliance with Regulatory guidelines.

Please consider my qualifications and experience:

• MWCC (Medical Writing Certification Commission)
• Proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills
• Medical writer in the pharmaceutical industry
• Complete knowledge of the medical writing industry
• Demonstrate expertise with grammar, syntax and format
• Hands-on laboratory experience in PCR and next generation sequencing technologies
• Knowledge on molecular diagnostics or on different NGS platforms is considered an asset
• Technical expert with customer-orientation, good communicator and team-player, self-motivated to work independently

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

Previously, I was responsible for professional, expert advice to medical and clinical teams on all matters relating to the production of clinical documents, regulatory submissions, and/or presentations/publications.

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

• Excellent oral communication skills with clients, KOLs, and BioPharm team members, strong listening and analytical skills
• Knowledge of the AMA Manual of Style preferred
• Experience in medical writing or relevant pharmaceutical/CRO related experience with working knowledge of clinical research and biostatistics
• Committed to delivering excellence, pro-active, a strong team focus
• Proficiency in computer word processing programs
• Extensive knowledge of English grammar with a familiarity with AMA style guide
• Understanding of FDA and ICH regulations and guidelines strongly preferred
• Have written CSRs, clinical protocols, clinical protocol amendments, IBs, and IB updates

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

In my previous role, I was responsible for medical/scientific support and responses or education as appropriate per SOPs, ethics and Compliance guidelines and local country laws.

Please consider my qualifications and experience:

• Careful attention for detail and accuracy
• Additional qualification in medical writing
• Doctorate in life sciences preferred
• Strong scientific background in cellular immunology or related field
• Proficiency with MS Office Suite, Endnote, and templates
• Efficient, organized, and able to handle short timelines in a fast-paced environment
• Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, CTXs, NDAs and MAAs
• Experience with Phase I-III clinical trials including international regulatory requirements

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

In the previous role, I was responsible for medical and scientific direction to BPS-US facilities on medical matters associated with donor eligibility and plasma suitability.

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

• Expertise regarding Clinical Study Report (CSR) and appendices
• Experience with event and drug coding dictionaries
• Knowledge and experience with Design History File, Technical File, Design Dossier, Clinical Study Report, Clinical Evaluation Report content templates
• Expert in word processing, flow diagrams, and spreadsheets
• Experience with FDA and international regulations (device, , 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155, MEDDEV, EU MDR)
• Significant work experience in publication development in the biotechnology industry or a specialty vendor
• Minimum of 12- 20 yrs experience of regulatory writing and submission experience
• BS, MS, RN, PharmD, or doctorate in a scientific or medical field

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

In the previous role, I was responsible for hCPs with concise and unbiased medical and scientific information (within corporate guidelines) including disease state topics of interest as well as safe and appropriate use of Teva products;.

Please consider my experience and qualifications for this position:

• Be able to juggle multiple priorities and adapt quickly to new situations and new project demands
• Escalates conflict appropriately
• Demonstration of strong medical-writing skills as evidenced by publications in peer-reviewed journals
• Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables
• Readily adaptable to changes in priorities
• Able to interact productively with a variety of personalities and to work effectively in an international environment
• Experience in performing medical-database searches (e.g., Medline, PubMed)
• Extensive knowledge of regulatory requirements and documents, both U.S. and International