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Manager, medical writing skills for your resume and career

Updated January 8, 2025
3 min read
Below we've compiled a list of the most critical manager, medical writing skills. We ranked the top skills for managers, medical writing based on the percentage of resumes they appeared on. For example, 19.9% of manager, medical writing resumes contained medical writing as a skill. Continue reading to find out what skills a manager, medical writing needs to be successful in the workplace.

15 manager, medical writing skills for your resume and career

1. Medical Writing

Here's how managers, medical writing use medical writing:
  • Represent Global Medical Writing department on clinical development cross-functional teams and project initiatives.
  • Developed Medical Writing Department budget in collaboration with Vice President.

2. Clinical Study Reports

Here's how managers, medical writing use clinical study reports:
  • Condensed content from clinical study reports for posters that represented research at major pharmaceutical conferences, targeted largely for European audiences.
  • Provided medical-based text gleaned from research papers and nonclinical study reports into summaries according to ICH guidelines.

3. Project Management

Here's how managers, medical writing use project management:
  • Led cross-functional projects, demonstrated project management skills and an ability to coordinate deliverables, timelines, and processes.
  • Managed multiple projects under tight deadlines using collaborative project management tools.

4. 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 managers, medical writing use qc:
  • Represented the Medical Writng department on cross-functional teams related to document QC and electronic submissions.
  • Performed QC on regulatory documents.

5. Medical Writers

Here's how managers, medical writing use medical writers:
  • Led resource planning/capacity management for Medical Writers and Clinical Publishers.
  • Delivered various metrics and project tracking systems to support the needs of the Medical Writers and Clinical Publishers.

6. Study Protocols

Here's how managers, medical writing use study protocols:
  • Reviewed study protocols and client user requirements.

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7. Direct Reports

Here's how managers, medical writing use direct reports:
  • Supervised and managed activities of 2 to 5 direct reports and contractors, providing metrics for resourcing.
  • Managed direct reports as well as other writers on a project basis.

8. Clinical Data

Here's how managers, medical writing use clinical data:
  • Entered and QC'd clinical data.
  • Enter and QC clinical data.

9. 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.

Here's how managers, medical writing use nda:
  • Authored clinical study reports required for the submission of New Drug Applications (NDA).
  • Compiled both clinical and nonclinical tables according to global template as required for IB Updates and IND and NDA submissions.

10. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how managers, medical writing use medical devices:
  • Write review articles for journal publication that described the clinical use of marketed medical devices summarized over 5-year periods.
  • Performed regular searches in MAUDE database to evaluate issues against competing medical devices.

11. Literature

Here's how managers, medical writing use literature:
  • Performed monthly literature searches to identify new information on assigned therapeutic or product.
  • Leave Behind Literature on Pemetrexed in Advanced Non-Small Cell Lung Cancer.

12. Investigator Brochures

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

13. Clinical Operations

Clinical operations caters to the administration of the drug development process by ensuring there is proper planning, appropriate conduct through the process, safety of patients and use of quality data. It also encompasses facilitating effective communication between the different study sites and sponsors of the drug process.

Here's how managers, medical writing use clinical operations:
  • Helped to centralize all clinical writing efforts into the Clinical Operations organization.
  • Performed quality control of Clinical Operations section of Annual Report.

14. 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.

Here's how managers, medical writing use ind:
  • Produced IND and NDA reports for FDA submission, including creation and QC of hyperlinks.
  • Established several reports that were included into IND submission.

15. ECTD

Here's how managers, medical writing use ectd:
  • Develop fully ICH-compliant eCTD and other submission templates.
  • Served as IT liaison/lead user for eCTD templates.
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List of manager, medical writing skills to add to your resume

Manager, medical writing skills

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

  • Medical Writing
  • Clinical Study Reports
  • Project Management
  • QC
  • Medical Writers
  • Study Protocols
  • Direct Reports
  • Clinical Data
  • NDA
  • Medical Devices
  • Literature
  • Investigator Brochures
  • Clinical Operations
  • IND
  • ECTD
  • Informed Consent
  • CTD
  • Clinical Trials
  • QA
  • Style Guides
  • Pharmacokinetics
  • Medical Journals
  • Immunology
  • Drug Safety
  • RAPS

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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