What does a senior medical writer do?
A Senior Medical Writer is responsible for writing comprehensive medical texts and composition for various audiences according to required themes and subjects. Senior Medical Writers maintain the accuracy and authenticity of all information by coordinating with medical professionals and other related parties to gather data. They also study recent trends and innovations within the medical industry and share findings with the clients for further study. A Senior Medical Writer must have excellent communication and leadership skills, especially in training junior writers and setting recommendations for high-quality publications.
Senior medical writer responsibilities
Here are examples of responsibilities from real senior medical writer resumes:
- Manage the contractor for the eCTD compilation and submission.
- Prepare CSRs and manage the writing of CSRs by contract writers.
- Manage the quality control (QC) and quality assurance (QA) review and response processes for these documents.
- Create and maintain account profiles for contributors, including writing of biographies, gathering headshots, and creating and managing accounts.
- Work within the confines of a regulate document management system, prepare documents in eCTD format under GCP and ICH guidelines.
- Develop a strong knowledge of (GxP, ICH) regulatory guidelines.
- Prepare copy decks for FDA legal reviews.
- Approach are accepted by FDA and European regulatory authorities.
- Involve in several successful BLA/MAA submissions, and more recently in eCTD submission documents.
- Excel sheets go through an ETL process and then load in to an oracle database.
- Provide finalized narrative which incorporates client clinical team review comments as well as any client QC findings.
- Wrote/Edite manuscript content for peer-review journals, PowerPoint slide presentations, posters for professional symposia, abstracts, and press releases.
- Develop copy for web-base educational programs for physicians and patients.
- Perform monthly literature searches to identify new information on assign therapeutic or product.
- Assist in the identification of patients requiring safety narratives and prioritization of narrative writing schedules for clinical oncology studies.
Senior medical writer skills and personality traits
We calculated that 10% of Senior Medical Writers are proficient in Medical Writing, Clinical Data, and Clinical Study Reports. They’re also known for soft skills such as Detail oriented, Imagination, and Technical skills.
We break down the percentage of Senior Medical Writers that have these skills listed on their resume here:
- Medical Writing, 10%
Reviewed and provided feedback on completed Medical Writing Assessment instruments for potential medical writers and submitted for final appraisal to management.
- Clinical Data, 7%
Entered and QC'd clinical data.
- Clinical Study Reports, 6%
Involved in interpretation of clinical research data analyses and writing of clinical study reports for biotechnology and multinational pharmaceutical companies.
- Clinical Research, 5%
Managed writing and editing of publications and regulatory documents to support clinical research in oncology.
- FDA, 5%
Completed numerous integrated clinical/statistical reports (Phases 1 through 3) for submission to FDA.
- Patients, 5%
Ensured medical evacuation assets were properly equipped to handle patients.
Most senior medical writers use their skills in "medical writing," "clinical data," and "clinical study reports" to do their jobs. You can find more detail on essential senior medical writer responsibilities here:
Detail oriented. One of the key soft skills for a senior medical writer to have is detail oriented. You can see how this relates to what senior medical writers do because "technical writers create instructions for others to follow." Additionally, a senior medical writer resume shows how senior medical writers use detail oriented: "interviewed patients and compiled data to write highly detailed medical reports for medical providers and insurance carriers. "
Imagination. Another essential skill to perform senior medical writer duties is imagination. Senior medical writers responsibilities require that "technical writers must think about a procedure or product as if they are someone who does not have technical knowledge." Senior medical writers also use imagination in their role according to a real resume snippet: "ensured that inventiv health clinical meets client expectations for medical writing projects. "
Technical skills. This is an important skill for senior medical writers to perform their duties. For an example of how senior medical writer responsibilities depend on this skill, consider that "technical writers must be able to understand complex information." This excerpt from a resume also shows how vital it is to everyday roles and responsibilities of a senior medical writer: "sop technical writer for fda regulatory requirements in information technology. ".
Writing skills. A big part of what senior medical writers do relies on "writing skills." You can see how essential it is to senior medical writer responsibilities because "technical communicators must have excellent writing skills to be able to explain technical information clearly." Here's an example of how this skill is used from a resume that represents typical senior medical writer tasks: "helped to centralize all clinical writing efforts into the clinical operations organization. "
The three companies that hire the most senior medical writers are:
- QuintilesIMS196 senior medical writers jobs
- Highmark51 senior medical writers jobs
- MMS30 senior medical writers jobs
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Compare different senior medical writers
Senior medical writer vs. Writing consultant
The primary role of an Associate Editor is to ensure that subordinates submit high-quality content. They review and edit copies, set deadlines, and supervise the production details of magazines, newspapers, books, or websites.
While similarities exist, there are also some differences between senior medical writers and writing consultant. For instance, senior medical writer responsibilities require skills such as "clinical data," "clinical study reports," "clinical research," and "fda." Whereas a writing consultant is skilled in "writing process," "proper grammar," "grammatical errors," and "content writing." This is part of what separates the two careers.
Writing consultants tend to reach similar levels of education than senior medical writers. In fact, writing consultants are 1.9% less likely to graduate with a Master's Degree and 11.7% less likely to have a Doctoral Degree.Senior medical writer vs. Associate editor
Managing editors are individuals who coordinate and oversee the editorial activities of a publication. They administer the daily operations or a website or publication, such as generating ideas and planning and editing content. Their responsibilities include the recruitment, promotion, and firing of staff members. They even create and implement deadlines. Great managing editors are those who are updated on the latest trends and make informed decisions. They should also be equipped with skills in management and coaching.
Each career also uses different skills, according to real senior medical writer resumes. While senior medical writer responsibilities can utilize skills like "medical writing," "clinical data," "clinical study reports," and "clinical research," associate editors use skills like "wordpress," "web content," "seo," and "edit content."
In general, associate editors achieve similar levels of education than senior medical writers. They're 3.9% less likely to obtain a Master's Degree while being 11.7% less likely to earn a Doctoral Degree.Senior medical writer vs. Managing editor
A content editor is an individual who is responsible for proof-reading articles written by content writers and write blog posts to promote the products and services of an organization. Content editors are responsible for producing monthly newsletters and optimize written pieces to increase user engagement. They need to interact with the consumers with the purpose of sourcing feedback on the content's impact actively. Content editors must also conduct business research on current trends to give the company an edge over the competition.
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from senior medical writer resumes include skills like "medical writing," "clinical data," "clinical study reports," and "clinical research," whereas a managing editor is more likely to list skills in "web content," "editorial content," "seo," and "editorial calendar. "
Managing editors typically earn similar educational levels compared to senior medical writers. Specifically, they're 4.8% less likely to graduate with a Master's Degree, and 12.2% less likely to earn a Doctoral Degree.Senior medical writer vs. Content editor
Types of senior medical writer
Updated January 8, 2025
