If you’ve put reasonable effort into the search and selection process, including the final step of checking references, chances are you’ve selected a medical writer who already works quite effectively with most clients.  Nevertheless, to ensure the best results and make sure you don’t become the exception, the following issues should be addressed up front, at the beginning of the relationship:

Contract – It should go without saying that using a written contract is imperative, to spell out clearly the tasks, responsibilities, deadlines, compensation, etc. in as much detail as reasonably possible.  Both sides make assumptions when the specifics are not available, and this is where trouble and misunderstandings arise.  I have seen and used contracts ranging in length from 1 page to 18 pages.  Generally, simpler is better, provided all the basic points are clearly addressed.  Allow sufficient time to ‘work through’ any issues in negotiating the contract, so this is not left to ‘the night before’ with untimely compromises or hasty omissions for either party.

Timetable – Next to compensation, the project timetable is probably the most common source of misunderstanding or friction.  The timetable must address not just final deadline, but first and/or interim draft dates, database lock date(s), data availability, and turnarounds (both writer and client).  A complete understanding of potential changes/impacts to the existing timetable must also be reached:  will all future dates slide if one earlier date is missed?  Good medical writers have developed strong project scheduling skills – it is generally not “OK” to run a couple weeks behind schedule and expect previously missed deadlines to simply be ‘made up’ by the writer via faster work.

Contact Person(s) – Specify clearly to whom the writer will report, their availability, and if there are multiple people, what function or priority is to be paid to each.  Nothing frustrates a writer’s efforts more than conflicting feedback from differing client team members without clarity as to whose feedback should prevail.  Please also clarify with whom the writer should correspond regarding invoices and payment, if different from the main contact person.

Feedback: Form and Timing – will feedback take the form of a review meeting/call, or will it be written comments in Word or Acrobat?  How specific and detailed?  Will there be one or multiple reviewers, collated/collective feedback or independent.  In a new writer-client relationship, more frequent interim feedback serves to make both parties more comfortable with the direction of the project.  Note, however, that the number of reviewers and process can significantly change the timing and effort required to get the job done.

Meetings – It is a good idea to set expectations about the number, length and frequency of meetings the writer may be expected to attend, even if just
telephonically.  Remember, you are probably not the writer’s only client.  Unscheduled meetings can wreck havoc on the writer’s schedule and cause great friction, as he/she may be juggling other client deadlines, too.

Ultimately, the best working relationships are grounded in superior communication.  The stage is set by the contract process and discussion of the areas mentioned above, but both parties must be committed to open and frequent communication throughout the project to ensure that a remote working relationship goes as smoothly as possible.  This includes setting expectations about the methods and frequency by which the parties will communicate, as well as general availability and anticipated response times.

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While there is no shortage of medical writers, selecting a competent, experienced professional medical writer best suited to your project from among thousands available for hire can be a challenge.  By simply considering and prioritizing a handful of key selection criteria, you can establish an objective process and simplify the evaluation of the medical writers you have managed to find using the techniques in Part 1.   The following are the 7 most
commonly used selection criteria for freelance medical writers:

Education – The extent to which the medical writer is formally educated in health science is typically a key factor in the selection process.  However,
if consumers are the target audience for the project, then formal education may be less important than ‘experiential education’ acquired through work in that particular area.  When it comes to projects for clinical audiences, including regulatory documents, medical journals, or CME, a strong science or medical background is typically a prerequisite. Often ‘PhD required’ is used to set the bar high for potential candidates.  Sometimes advanced degrees are necessary, and other times they are simply used a screening tool.  For example, a writer with an educational background in English or Journalism would face a tough learning curve in clinical or regulatory settings, but may thrive in consumer or patient education. Typically, the minimum educational requirement is a bachelor degree in the health sciences, but depending upon your needs, educational factors as specific as the medical writer’s area of post-graduate research may also be considered.

Experience – Experience, measured either in years as a medical writer or quantity of documents produced, tends to be one of the top two selection criteria.  Years of experience in medical writing may be a great rule of thumb, but the number of documents of the type actually needed may be even more important.  Contrast a 20-year medical writer who may have just one or two manuscripts written, with a 5-year medical writer who has focused half of  his/her business on manuscripts, and consequently, has written dozens of them.  A certain level of experience in a particular therapeutic area (e.g.,
oncology) is also a possible consideration, again usually measured by number of documents rather than years.

Services – Consider the nature of services or document types offered by the medical writer in comparison with your medical writing project requirements.
Perhaps you’ve found an oncology medical writer (right therapeutic experience), but he/she doesn’t offer support services for meetings (not uncommon for writers) and thus may not be well suited to developing a CME slide deck.  Upon reviewing a writer’s bio you might realize you’ve found a top notch manuscript writer when you need a clinical study report?  In addition to industry experience and therapeutic area, make sure the writer offers the specific  type of service and/or document type you require.

Geography – Location has plummeted in importance in the medical writing industry.  More and more, even inside large companies, medical writing teams have become distributed virtual teams with members in remote locations, even home offices.  They may converge only on conference calls or perhaps online video calls. Imposing a requirement that a freelance medical writer be ‘local’ in order to facilitate weekly meetings or ‘days in the office’ will severely hamper your search.  Nevertheless, some companies may still require or prefer that a freelance medical writer be local, and if so, they should clearly communicate the requirement and rationale to potential candidates.

Samples –If samples are sought, ask for raw (not published) samples, which will reflect the writer’s work BEFORE it was edited by others (client team members, editors, etc.).  Requests for writing samples are typically reserved for newer, early career (<5 years) writers.  Many of the documents writers produce are confidential and thus cannot be shared, but they can have confidential or identifying information redacted to allow distribution.  This can be a tedious process and result in horribly difficult to read samples, so it should be used sparingly, if at all.  Lastly, writing “tests”, more commonly used for entry level employee (not freelancer) positions, should be avoided if you are evaluating experienced freelancers, who should have plentiful samples of previous work to evaluate.

Interviews – Eventually, you will want to speak directly with the candidate, assess their verbal skills and ease with which you can communicate, and determine the “fit” (a mix of personality, temperament, etc.), and this can only be accomplished in an interview.  Personal interviews should be utilized as a
last step, scheduled and conducted in a timely manner, and be short and to the point.  Offer ample opportunity for the candidate to ask questions, as you can learn just as much from the candidate’s questions as his/her answers.  A good candidate will likely demonstrate his/her expertise and skills simply by asking questions about the company and/or project that were not addressed in any preceding communications.

References – Placing calls or email inquiries to past clients should really be reserved for the final step – ‘affirming’ everything you’ve reviewed and  concluded – for someone you are otherwise ready to hire.  Of course you can expect that you will only be referred to ‘good’ references, but if the candidate scores well on all other selection criteria, and has a handful of good references, you are unlikely to hire a “lemon”.

No matter how you consider and/or rank the importance of the above criteria, ultimately the single most important selection factor is the medical writer’s ability to research and absorb information, organize and synthesize it, and then communicate it most effectively for the media type and audience.  Unfortunately the only way to evaluate this ability is to work directly with the freelancer on a project.  Yet by evaluating every freelance medical writing candidate carefully on each of the above criteria ranked according to you project’s needs, you stand to minimize the likelihood of any hiring regrets.

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While there really are countless methods for finding a medical writer to assist with your project, we will list and discuss only the top five internet-based techniques here. However, as with many things, hasty, last-minute searches often create disappointing results. Consider starting your search by “looking” for a freelance medical writer even before you need one. Let your colleagues and others in your professional network know that you need contract medical writers from time to time. Keep a handful of promising prospects ‘on file’ as you come across them. This will shorten the ‘search time’ to near zero when the need genuinely arises, so you can concentrate on the selection process and ensuring your choice is a good match for the project (and is available!). That said, once you find yourself needing to begin your search, here are five best places on the Internet to find a professional medical writer:

1. AMWA database –American Medical Writers Association, the primary trade association for medical writers in the U.S., maintains a searchable database of medical writers. A small $50 ‘subscription’ is required by non-members for three months of search privileges. Other professional societies (RAPS, ISMPP, DIA, etc.) also maintain databases of members, a portion of whom are freelance medical writers, but membership is required to search them, and none are as vast and detailed as the AMWA freelancer database. Furthermore, I suspect that most of the medical writers in these other databases are also listed in the AMWA database.

2. Google – One of the best ways to find anything these days, Google, is also a reasonably efficient method for locating a freelance medical writer. I say ‘reasonably efficient’ because larger medical writing firms tend to have greater resources to make themselves visible, so the freelancers tend to be somewhat harder to find (not on Page 1 of Google). However, by including specific terms such as the therapeutic area, document type (manuscript, slide deck, study report, etc.) and target audience (clinical, patient, consumer) to narrow your search, you can speed up and improve your results. Even so, it may be difficult to find more than just the small population of medical writers who have also managed to acquire some level of proficiency with search engine optimization.

3. LinkedIn – In addition to finding people by searching, if you are a LinkedIn member, you can search, read and post in one of numerous specialty ‘Groups’ within LinkedIn (e.g., Professional Medical/Scientific Writers) to help find a writer with the criteria you are seeking. Placing a ‘Wanted’ ad in the form of a posting publicizing your project need can prove very effective, as it will likely move with lightning speed through the LinkedIn network.

4. Facebook – The business use of Facebook ‘Pages’ is relatively new but expanding rapidly, and thus represents an upcoming contender in the methodology for finding medical writers. Here,too, identifying and searching groups specific to the writing community and/or therapeutic areas heighten the probability of finding the right skill set for your needs.

5. Freelancer Websites – A number of more general freelancer websites have medical writers who pay to advertise their services on them. Although these sites tend to have greater numbers of non-medical writers (copywriters, journalists, etc.), you can again use more specific search terms (therapeutic area, document type and audience) to find the medical writers who do use these forums to market themselves. Websites in this category include elance.com, guru.com, freelancer.com, findafreelancer.com, and ifreelance.com, among others.

There you have it – without leaving your desk you have access to all the medical writing talent you might ever need. I can’t imagine how difficult it must have been for companies to find their medical writers 10+ years ago. Frankly, much of the growth in the freelance medical writing industry is due to the ease with which freelancers can now be found. You just have to know where to look, and now you do!

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Medical Writing, Slides, & Regulatory Documents

Regulatory, Publications, Medical Education & Meetings

Science Author, Inc. provides expert medical writing, research, slide deck preparation and regulatory writing in a broad spectrum of therapeutic areas, including oncology, neurology, immunology, respiratory and ophthalmology and more. The scope of our medical writing services includes regulatory documents, clinical journal publications, medical education, and meeting presentations, coverage and synopsis. If you need assistance in any of these or related areas, contact us for a free consultation and proposal for your project.

Clinical trial documentation (Phase 1-4) Protocols, consent forms, clinical study reports, investigator brochures, other Drug submissions IND, EOP2 meeting package, NDA, CTD/eCTD, Briefing documents	Periodicals Primary manuscripts, review articles, journal supplements, and “letters to the editor” Event documentation Abstracts, posters, slide decks Other Newsletters, product monographs, book chapters

Provider education tools & patient education resources Pharma sales rep training materials CME slide decks & programs, CME test or discussion questions	Medical Meeting on-site coverage Advisory boards, national & satellite symposia, KOL meetings Meeting reports, meeting news updates & executive summaries

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“The quality of Marithea’s work has been consistently high, and her delivery of documents is always on time, many times earlier than her deadline.  Despite the fact that most of our communication is carried out via email and brief teleconferences, she always comprehends what is needed…  asking insightful questions that show she has full understanding of the process and exemplary attention to detail.  When I have a difficult assignment that needs to be completed within a tight timeframe, she is one of the first persons I consider.”
Lisa B., Vice President, Regulatory Operations
Sirion Therapeutics, Inc.

Dr. Goberville’s work is of the highest quality. We have engaged her for various types of projects including onsite conference coverage and manuscript development. She has a great deal of experience and is very clinically knowledgeable.  There has never been an occasion where we were disappointed with her work.  Simply put – “she gets it”.
Nathan K., Senior Director of Global Clinical Operations
PRIME Oncology, Inc.

“Thank you so very much for all of the work you have done on this project. You have been a rock throughout this process and a complete pleasure to work with. I heard nothing but positive feedback from the team whenever you were involved. This is can be a tough group, but they all very much appreciated everything you did. I’ve said it a hundred times, but, one hundred times more, thank you.”
Angela C., Senior Medical Writer
MedImmune, Inc.

“Thea is a take-charge person who is able to present various documents to clients as well as have direct conversations with faculty on data, etc.  She is an asset to our writing team and perfectionist in all of her work. In addition to writing skills, she is very professional on site at meetings and all interactions with clients and faculty.  When working with Thea I have a level of confidence knowing I have one of the best medical writers on my projects.”
Angela F., Account Manager
R&R Healthcare Communications

“It was a tremendous benefit to have your expertise on our team.  Your previous experience in clinical trial documentation development greatly expedited the development process and helped us to meet our commitments to the Principal Investigators.  Moreover, the fact that we received 100% approval on the documentation from our Regulatory Affairs department can be directly attributed to your extensive knowledge of the regulations and standards governing an international, multi-center trial.”
Paulena M., Technical Document Specialist
Digene, Inc.

“Thanks to Marithea for achieving the goal of a final draft CSR for our global phase 2 study ahead of that initially planned.   We appreciate your timeliness and attention to quality and detail you provided.”
Joseph P., Senior Vice President of Product Development
Cerimon, Inc.

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Request Information or Proposal

We welcome the opportunity for a free, no-obligation discussion of your project. All of our work is customized to meet the client’s exact specifications. For more information about our medical writing services, or to discuss the specific needs of your project(s), please complete this short form below. Please include the following information in your description:

• Service requested (e.g., writing, slides, backgroun research, referencing, editing, other)
• Therapeutic area(s) covered (e.g., oncology, neurology, immunology, etc.)
• Audience (Physician, Clinician, FDA, Pharma Sales)
• Document type (e.g., conference abstract, journal article, slide set, poster, etc.)
• Deadline

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Marithea Goberville, Ph.D.

President & Principal Medical Writer

Marithea is an accomplished and highly qualified medical, regulatory and scientific writer. With dozens of commercial biotech research products, scores of published and internal written works, and thousands of meeting hours and slides (advisory board, FDA review, trade and CME conferences) to her credit, she brings experience at every level of science, from laboratory research and product development to large-scale medical communication projects and clinical trials.  Marithea draws upon her superior research skills, analytical ability and medical writing expertise to assist clients with medical,  regulatory or scientific communication projects in the U.S. and abroad. Marithea’s education and experience best position her for projects addressing physician, scientist and clinical audiences in the topics of oncology, neuroscience, ophthalmology, respiratory, virology and other therapeutic areas. She thrives on the challenges of  developing clear and concise regulatory writing and slide presentations as well as all forms of journal publications and clinical trial documentation.

Through her company, Science Author, Inc., she provides fast, scientifically accurate and high-quality consulting and project deliverables, including regulatory filings, slide decks, manuscripts, abstracts, product monographs, posters, advisory board presentations, executive summaries, clinical study reports, study protocols, investigator’s brochures and other clinical documents.

Contact us for a free consultation.

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