The BioPharm industry presents a wide variety of opportunities for medical writers and editors. Many writers are MDs or PhDs but a doctoral degree is not required.
As we have discussed, the BioPharm industry is heavily regulated. Almost everything done must be documented and summarized for regulatory submissions. Some of these materials are written by the bench scientists or clinical staff who do the work, but for big projects, the help and guidance of an experienced medical writer is critical.
Medical writers in industry write for many audiences including regulatory reviewers, physicians, pharmacists, patients, the public, stockholders, etc. Medical writers draft protocols, Investigator Brochures, clinical study reports, and regulatory submissions such as INDs, and NDAs. In addition, medical writers in industry also prepare educational materials about products, such as slide sets and product monographs and well as scientific information for press releases.
Medical writers may be employees of BioPharm companies or may work for CROs, consulting firms, advertising agencies, or academic institutions. Many medical writers work on their own, as freelancers, often after careers in one of the above institutions.
Medical writers must be talented communicators; they must interpret scientific and medical information and present the results clearly and grammatically. They must be skilled in formatting tables, figures, and diagrams and must be able to keep track of multiple drafts from many contributors. Writers work independently at times but must also be able to collaborate with multidisciplinary teams on large complicated documents. The hardest part of being a writer may be taking criticism, i.e. literary criticism. When working on a large document like an NDA, most companies assemble a team of physicians, CRAs, regulators, scientists, and executives who review documents drafted by the writer. Every word, comma, and hyphen is scrutinized and there are many egos that must be balanced and massaged. After a few hours of discussion, it is left to the writer to record everyone’s contribution and blend the results together without losing the integrity of the document.
I have worked with many very talented medical writers. One of the best had a PhD in psychology, not pharmacology, but she has produced hundreds of beautifully crafted regulatory and educational documents for drugs and devices. I've often said that if you gave her a bunch of papers from the recycling bin she could generate two final reports and a publication. It is a lesson in humility to have her edit your document but the final results are worth it.
If you are thinking about a career as an independent medical writer, I would suggest that you look at a blog called biotechinkspots.com written by Dr. Susan E. Caldwell. I don't know Dr. Caldwell personally but I enjoy her website. She discusses many problems that freelance medical writers face in trying to manage their careers.
The American Medical Writers Association (AMWA) is a national organization for writers in industry and academia. AMWA some excellent online courses and regional and national workshops that can lead to Certification in Essential Skills; Composition and Publication; or Regulatory and Research. Their regional chapters sponsor local meetings that are good places for networking. We have provided a link on our Professional Organizations page in Resources.
As we have discussed, the BioPharm industry is heavily regulated. Almost everything done must be documented and summarized for regulatory submissions. Some of these materials are written by the bench scientists or clinical staff who do the work, but for big projects, the help and guidance of an experienced medical writer is critical.
Medical writers in industry write for many audiences including regulatory reviewers, physicians, pharmacists, patients, the public, stockholders, etc. Medical writers draft protocols, Investigator Brochures, clinical study reports, and regulatory submissions such as INDs, and NDAs. In addition, medical writers in industry also prepare educational materials about products, such as slide sets and product monographs and well as scientific information for press releases.
Medical writers may be employees of BioPharm companies or may work for CROs, consulting firms, advertising agencies, or academic institutions. Many medical writers work on their own, as freelancers, often after careers in one of the above institutions.
Medical writers must be talented communicators; they must interpret scientific and medical information and present the results clearly and grammatically. They must be skilled in formatting tables, figures, and diagrams and must be able to keep track of multiple drafts from many contributors. Writers work independently at times but must also be able to collaborate with multidisciplinary teams on large complicated documents. The hardest part of being a writer may be taking criticism, i.e. literary criticism. When working on a large document like an NDA, most companies assemble a team of physicians, CRAs, regulators, scientists, and executives who review documents drafted by the writer. Every word, comma, and hyphen is scrutinized and there are many egos that must be balanced and massaged. After a few hours of discussion, it is left to the writer to record everyone’s contribution and blend the results together without losing the integrity of the document.
I have worked with many very talented medical writers. One of the best had a PhD in psychology, not pharmacology, but she has produced hundreds of beautifully crafted regulatory and educational documents for drugs and devices. I've often said that if you gave her a bunch of papers from the recycling bin she could generate two final reports and a publication. It is a lesson in humility to have her edit your document but the final results are worth it.
If you are thinking about a career as an independent medical writer, I would suggest that you look at a blog called biotechinkspots.com written by Dr. Susan E. Caldwell. I don't know Dr. Caldwell personally but I enjoy her website. She discusses many problems that freelance medical writers face in trying to manage their careers.
The American Medical Writers Association (AMWA) is a national organization for writers in industry and academia. AMWA some excellent online courses and regional and national workshops that can lead to Certification in Essential Skills; Composition and Publication; or Regulatory and Research. Their regional chapters sponsor local meetings that are good places for networking. We have provided a link on our Professional Organizations page in Resources.