Hi Ed,
I currently work as a Regulatory Writer, and I agree with what Julie and Gretchen said.
I don't know if it would help, but below I copied a description of job opening for regulatory writer position from LinkedIn. You can look under Qualifications and Competencies to see what medical writers need to know to do their job well. Please note, this job description is for writers who would author regulatory documents. Writers who work on primary scientific manuscripts may need a different set of skills...
I guess if you type Medical Writer into LinkedIn job search engine, you can get to many more job descriptions...
Best wishes,
Mayya
------------------
The Senior Medical Writer will report to the Head of Medical Writing and will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write independently as well as work effectively with cross functional colleagues to develop documents efficiently and with high quality.
RESPONSIBILITIES
* Write or oversee the writing of regulatory submission documents (e.g., clinical protocols, investigator brochures [IBs], clinical study reports [CSRs], eCTD/BLA clinical summaries)
* Maintain timelines and ensure smooth and effective document management from conception to final signature (i.e., generation of a blank document to a final approved version), including management of various processes (e.g., QC, formatting, publishing, document archiving)
* Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
* Lead or oversee document review and comment resolution meetings with cross-functional teams
* Analyze and interpret clinical study data
* Perform literature-based research to support writing activities
QUALIFICATIONS
* BS, MS, or doctorate in a scientific or medical field
* 8+ years in the biotechnology/pharmaceutical industry
* Experience in rare diseases, oncology and/or inflammation preferred
* Demonstrated experience as a primary author, writing and editing regulatoryscientific documents; has written protocols, IBs, CSRs, and worked on at least one eCTD/NDA/BLA submission
* Skilled at data analysis
* Strong document management and project management skills, along with initiative and ability to be productive with minimal supervision
* Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
* Understands and effectively responds to multicultural communication styles and business practices with vendors, partners, and internal colleagues
* Ability to build and maintain effective partnerships, both internally and externally
* Holds self and others accountable for adherence to high ethical standards; adopts and maintains
Competencies and Attributes
* Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the core cultural values of courageous, creative and selfless
* Exceptional oral and written communication skills
* Flexible; adapts work style to meet organization needs
* Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
* Dedicated to quality and reliability
* Excellent computer skills (Microsoft Office Suite; Project and Visio experience a plus)
------------------------------
Mayya Shveygert, Ph.D.
Sr. Regulatory Writing Associate Amgen, Inc.
South San Francisco, CA USA
Original Message:
Sent: 12-Jul-2016 09:40
From: Gretchen Upton
Subject: Medical Writer
Hello,
If they are a contract medical writer, you will need to qualify them as a supplier, add to your supplier list and then periodically evaluate. Perhaps you could review several JD's, draft your qualifications then evaluate accordingly.
Gretchen
------------------------------
Gretchen Upton RAC
San Antonio TX
United States
Original Message:
Sent: 11-Jul-2016 03:09
From: Ed Lin
Subject: Medical Writer
What are the qualifications of a Medical Writer?
This may not be required in the US regulatory community but experience is important
and sometimes critical. I know a few global pharma companies are implementing the
SME (subject matter expert) into their quality system, so I am trying to do so for our
company to establish an SME of Medical Writing.
Ed Lin
VP, Quality & Compliance
United Biomedical Inc
Hauppauge, NY
This e-mail and any files transmitted with it are intended only for the person or entity to which it is addressed and may contain confidential material and/or material protected by law. Any retransmission or use of this information may be a violation of that law. If you received this in error, please contact the sender and delete the material from any computer.