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Scientific writer skills for your resume and career
15 scientific writer skills for your resume and career
1. IND
IND which stands for "Investigational New Drug" are drug applications submitted to the Food and Drug Administration (FDA). Some IND is submitted to start clinical trials to gain marketing approval for commercial purposes while others are purely research-oriented to study an unapproved drug for a patient population or new evidence.
- Established several reports that were included into IND submission.
- Prepared the 1st edition of an IDB and SA for the IND submission.
2. NDA
A non-disclosure agreement, also called a confidentiality agreement, refers to the constitutional paperwork that compels two parties to keep each other's data fully confidential. Trade secrets and different types of sensitive data are kept secure via an NDA. If one party doesn't keep up his end of the bargain, they will break the law and may face charges.
- Provide nonclinical NDA Sections 2.6 and 2.4, and clinical NDA Section 2.7 summaries for a diagnostic PET imaging agent.
- Participated in developing strategies for supporting Regulatory Affairs in submitting new drug applications (NDA).
3. Abstracts
Abstracts highlight the vital information of a patient's medical record. They are mostly summarized and organized into different categories, consisting of essential data.
- Write and review abstracts, posters, manuscripts, reviews, product monographs, and PowerPoint presentations Publication planning and competitive intelligence
- Write and create scientific/technical product support materials including Abstracts, manuscripts, Posters, and PowerPoint presentations.
4. Regulatory Submissions
Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.
- Served as lead writer for regulatory response documents and key components of regulatory submissions.
- Prepared documents for regulatory submission.
5. Proofreading
- Organized and consolidated information into standard report formats, preparing and proofreading correspondence and documents in accordance with HIPAA regulations.
- Exhibited proficiency in researching, writing, editing, and proofreading.
6. Clinical Study Reports
- Evaluated and summarized safety and pharmacokinetic data for clinical study reports.
- Involved in interpretation of clinical research data analyses and writing of clinical study reports for biotechnology and multinational pharmaceutical companies.
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- Involved in several successful BLA/MAA submissions, and more recently in eCTD submission documents.
- Managed the contractor for the eCTD compilation and submission.
8. QC
Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.
- Performed QC on regulatory documents.
- Managed the quality control (QC) and quality assurance (QA) review and response processes for these documents.
9. Clinical Trials
- Use to follow and track clinical trial milestones for assigned projects.
- Translated clinical trials data, pharmaceutical profiles, and marketing information into accessible learning tools.
11. Drug Safety
- Worked closely with Drug Safety colleagues and extracted data from Toxicology reports after reviewing them.
- Prepared drug safety updates and investigator drug brochures.
12. Medical Writing
- Provided medical writing for a company specializing in post-marketing pharmacovigilance and pharmacoepidemiologic research and consulting for the pharmaceutical industry.
- Reviewed and provided feedback on completed Medical Writing Assessment instruments for potential medical writers and submitted for final appraisal to management.
13. Scientific Content
- Plan and develop medial/scientific content for peer-reviewed journal articles, scientific monographs, and other print or e-print manuscripts;.
- Prepared written scientific content for manuscripts and abstracts for clients as a self-employed subcontractor.
14. Pharmacokinetics
- Brief expansion into pharmacokinetics reporting.
- Participate in the review, analysis and interpretation of pharmacokinetic (PK) and pharmacodynamics (PD) data.
15. GLP
GLP stands for "good laboratory practice." This refers to the integrity and quality measures that non-clinical laboratories have in place to ensure accurate research and market testing. GLP is most often used in pharmaceutical companies where new drugs must be tested before being approved for sale, but the practice can also be used in food packaging and preparation test centers.
- Contributed to approximately 400+ GLP and non-GLP studies and authored 16 TK reports.
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What skills help Scientific Writers find jobs?
Tell us what job you are looking for, we’ll show you what skills employers want.
What scientific writer skills would you recommend for someone trying to advance their career?
Associate Professor and Director of Undergraduate Studies, University of Minnesota
I can't say that I know of a sure bet, but places that deal with medical technology, healthcare, and related fields are probably going to need people well-trained to communicate specialized knowledge to a variety of audiences and in a variety of ways. Telemedicine seems to have gained a more permanent stronghold in the healthcare system, and I imagine that the various communication channels involved in this new way of practicing medicine will open opportunities for well-trained graduates, such as ours who are willing to be pioneers in this area.
What type of skills will young scientific writers need?
Associate Professor of English, California University of Pennsylvania
List of scientific writer skills to add to your resume

The most important skills for a scientific writer resume and required skills for a scientific writer to have include:
- IND
- NDA
- Abstracts
- Regulatory Submissions
- Proofreading
- Clinical Study Reports
- ECTD
- QC
- Clinical Trials
- SharePoint
- Drug Safety
- Medical Writing
- Scientific Content
- Pharmacokinetics
- GLP
- Scientific Literature
- FDA
- ICH
- Book Chapters
- Scientific Journals
- Study Protocols
- Informed Consent
- Scientific Publications
- NIH
- Technical Reports
- Scientific Reports
- Scientific Articles
- Educational Materials
- Scientific Data
- Statistical Analysis
- Quality Control Reviews
- American Association
- Medical Education
- Slide Presentations
- Drug Applications
- Analytical Reports
- Data Analysis
- Breast Cancer
- PowerPoint
Updated January 8, 2025