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Director, medical writing skills for your resume and career

Updated January 8, 2025
2 min read
Below we've compiled a list of the most critical director, medical writing skills. We ranked the top skills for directors, medical writing based on the percentage of resumes they appeared on. For example, 22.8% of director, medical writing resumes contained medical writing as a skill. Continue reading to find out what skills a director, medical writing needs to be successful in the workplace.

15 director, medical writing skills for your resume and career

1. Medical Writing

Here's how directors, medical writing use medical writing:
  • Executed all departmental hiring, training, evaluation and retention of regulatory and medical writing associates.
  • Served as Project Manager for client-related projects that primarily focused on medical writing activities within TKL.

2. Regulatory Submissions

Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.

Here's how directors, medical writing use regulatory submissions:
  • Consulted with clients in the preparation of regulatory submission documents (INDs, NDAs, PMAs, and eCTDs).
  • Served as lead writer for regulatory response documents and key components of regulatory submissions.

3. Clinical Study Reports

Here's how directors, medical writing use clinical study reports:
  • Participated in template development for protocols, clinical study reports, and assisted in development of company style guide.
  • Involved in interpretation of clinical research data analyses and writing of clinical study reports for biotechnology and multinational pharmaceutical companies.

4. Project Management

Here's how directors, medical writing use project management:
  • Provided support for other departments, including Project management and Business Development activities.
  • Experienced in working extensively with other teams like Regulatory Affairs, Project Management, Marketing and Medical Affairs for fast-paced submissions.

5. Clinical Research

Here's how directors, medical writing use clinical research:
  • Provided writing support for preclinical and clinical research, process development, and CMC.

6. ECTD

Here's how directors, medical writing use ectd:
  • Involved in several successful BLA/MAA submissions, and more recently in eCTD submission documents.
  • Managed the contractor for the eCTD compilation and submission.

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7. CTD

Here's how directors, medical writing use ctd:
  • Prepared regulatory documents, including protocols, investigator brochures, IND submissions, CTD submissions.

8. Investigator Brochures

Here's how directors, medical writing use investigator brochures:
  • Introduced use of desktop publishing for Clinical Investigator Brochures.
  • Prepared Investigator Brochure update and protocol amendments.

9. 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.

Here's how directors, medical writing use qc:
  • Managed the quality control (QC) and quality assurance (QA) review and response processes for these documents.
  • Provided finalized narrative which incorporates client clinical team review comments as well as any client QC findings.

10. Risk Management

Risk management is the method of recognizing, evaluating, and managing risks to an organization's resources and profits. Financial insecurity, regulatory liability, strategic management mistakes, incidents, and natural hazards are just some of the challenges or dangers that could arise. For digitalized businesses, IT security vulnerabilities and data-related threats, as well as risk management techniques to mitigate them, have become top priorities.

Here's how directors, medical writing use risk management:
  • Led development of comprehensive Risk Management Program for MS program when on clinical hold.
  • Establish policies and procedures for clinic operations, as well as, manage regulatory compliance issue implementation and risk management applications.

11. Clinical Program

A clinical program is the sum of all clinical services rendered to patients directly in a clinical setting. It also refers to the programs in a school setting that offers practical knowledge and exercises to students in clinical sciences who are under supervision by a licensed clinical practitioner. Clinical programs expose students to first-hand medical experience, and prepare them for the task ahead.

Here's how directors, medical writing use clinical program:
  • Analyzed and summarize efficacy and safety data from Phase II-III clinical programs.

12. 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.

Here's how directors, medical writing use abstracts:
  • Developed abstracts that were accepted and published in the peer-reviewed literature (shown in list of publications).
  • Prepared multiple abstracts, posters, presentations, and manuscripts for oncology and MS studies.

13. Advisory Committee

Here's how directors, medical writing use advisory committee:
  • Managed and ensured writing and quality control resources for pre-NDA briefing book for advisory committee for cardiovascular compound.

14. Informed Consent

Here's how directors, medical writing use informed consent:
  • Review protocols and informed consent documents for consistency.
  • Developed clinical trial protocols for use of CEFIZOX in obstetrics, informed consent document, and monitored clinical studies.

15. Ich

Here's how directors, medical writing use ich:
  • Created and modified company document templates to ensure ICH compliance and efficiency.
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List of director, medical writing skills to add to your resume

Director, medical writing skills

The most important skills for a director, medical writing resume and required skills for a director, medical writing to have include:

  • Medical Writing
  • Regulatory Submissions
  • Clinical Study Reports
  • Project Management
  • Clinical Research
  • ECTD
  • CTD
  • Investigator Brochures
  • QC
  • Risk Management
  • Clinical Program
  • Abstracts
  • Advisory Committee
  • Informed Consent
  • Ich
  • Statistical Analysis
  • Press Releases
  • Phase III
  • Endnote

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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