1 January 2011                 Published weekly by Biotech Ink, LLCVol 4 No 1

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Inside the Insider

5 Things a Contract Medical Writer Needs to Start Working

by Suzanne Canada, PhD; edited by Susan E Caldwell, PhD

Open Jobs and Gigs
Director, Regulatory Affairs; Location Not Specified
Scientific Writer; Gaithersburg, MD

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5 Things a Contract Medical Writer Needs
to Start Working
by Suzanne Canada, PhD
edited by Susan E Caldwell, PhD 
Posted on 16 December 2010 to Suzanne Canada's blog, TanagerPerspectivesBlog, and on 3 January 2011 to Susan Caldwell's blog, Biotech Ink Spots.
After several years as an in-house writer, I have launched my freelance medical writing career. In addition to having skill at crafting high-quality, accurate documents, ...and being just delightful to work with..., one way I've learned I can demonstrate value to my clients is by working efficiently.

People in office
When I begin working for a new client, I'm usually anxious to get to work. But some of the non-writers I've reported to don't understand what a writer needs to start working.  In fact, sometimes the lack of the "write" resources causes delays in getting the work done on time, or it can hamper the writer's ability to produce an optimal work product.

On the flip side, most of us know that having the appropriate tools can enhance the work product and project timeline. So, here's my list of some of the important resources that writers need in order to be productive:

1.       A good writing space. It makes no sense to hire a professional writer, and then require them to sit for eight hours a day in a hall next to the elevators, or in a cube next to the kitchen.  The medical writer's work is very detail oriented, with a need to focus on data-heavy material; so, the writer needs a quiet place to do uninterrupted work.

2.       A good computer set-up.  Since the writer's primary job is writing, it's helpful to have a large computer screen (not the 15-inch diagonal that was in storage from 5 years ago) and a desk that won't put you in the hospital. Up-to-date software that is compatible with the rest of the client's staff is a necessity, of course. At a minimum, this usually includes Microsoft Office, Adobe Acrobat (full version, not the reader), and Outlook (or other communication software).

3.       Training on company procedures and processes.  Although experienced and probably current on their computer skills, writers should be trained on relevant SOPs, templates, style guides, or procedures. Companies must train contractors as well as employees on these processes, and can be "dinged" in an audit if they don't. Many client companies, though, don't think about this responsibility, so it's a good idea to prompt them about writer training. Most will appreciate the reminder.   

Computer, information4.       Access to information.  Most clinical, regulatory, and research staff are unaware of the detail and types of information that comprise reports, so it's best to give the writer access to the tables, listings, figures, and other relevant data at the start of the writing process.  At one company, it took me two weeks to get access to the location where all the documents were kept, because of justifications required by IT. Sometimes clients don't realize that this lack of access to critical documents can hamstring the document development project and cause the writing team to miss deadlines.

5.       Access to reviewers and other key people. The writer needs to know the people on the project team, including their roles in the organization.  This may mean giving the writer an org chart, inviting her or him to key meetings, or providing a list of the people on the team so introductions can happen. Certainly, it means the writer should be included in writing project team meetings and emails that pertain to the document's content development. Optimally, when the writer comes on board, someone in house should facilitate the introductions, so that everybody knows who the writer is.

The medical writer's role is at a critical point in product development that can profoundly speed up or slow down the product launch date. Bringing in a contract medical writer can get document projects off the ground that would otherwise languish for months or years, saving companies time and, in the end, a great deal of money. It makes sense for those who hire the writers to ensure up front that the writer's working environment has the resources needed to produce a high-quality, timely work product. Making sure that the right environment is available for the writer is time and effort well invested.


About the Author
Suzanne Canada, PhD

Suzanne Canada, PhD, is a freelance medical writer with more than 10 years of experience in the biotechnology industry; she also has AMWA editing and writing core certification. SuzanneSuzanne Canada, PhD specializes in developing documents that support BLA, IND, and NDA submissions to the United States FDA. You can find more information about Suzanne on her company website, www.TanagerMW.com.

Open Jobs and Gigs for Medical Writers
Susan E Caldwell, PhDThe jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters. 

Because of the tough job market, the Insider now lists open jobs worldwide that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples are biostatistician, director of clinical research, and other clinical research titles.

If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider.
Director, Regulatory Affairs
Location Not Specified


The appropriate candidate will lead all regulatory employees and activities, and will be responsible for interacting with regulatory agencies and translating regulatory requirements into a workable strategy/plan.




Setting up and operating a smoothly-running regulatory function

Evaluating, selecting, and developing regulatory personnel capable of fully functioning as a credible representative for the Regulatory Affairs function

Evaluating, selecting, and developing regulatory personnel capable of compiling scientific information, completing regulatory applications, and coordinating/managing the application and approval process

Overseeing all annual registrations and license renewals

Obtaining the earliest possible regulatory approvals for our medical technologies and devices

Providing regulatory expertise to executive management (business, scientific, and operations/manufacturing executives)

Coordinating, collaborating, and participating with Quality function in all internal and external audits

Functioning as a subject-matter expert for other regulatory personnel


Approximately 10 years experience leading a regulatory function in the biotechnology industry

Must be a skilled enabler, team builder, and mentor

Must be able to demonstrate in-depth knowledge of regulatory issues and processes affecting biotechnology in general, and diagnostic tests/devices in particular

Must be able to demonstrate effective project management skills and efficient multi-tasking skills

Must know how to establish credibility with scientific experts and business leaders


Please email resumes to stephen maroda@centerpointstaffing.com.

Scientific Writer
Gaithersburg, MD

Major Duties and Responsibilities

Under minimal supervision, the Scientific Writer writes and/or provides editorial support for complex integrated development and CMC regulatory documents such INDs, IMPDs, CTAs, NDAs, BLAs, annual reports, development reports, and responses to questions or information requests from regulatory agencies. Other responsibilities include:

Leading the process of critical review of development and regulatory documents and incorporating multiple reviews into successive drafts

Managing scientific writing activities associated with multiple projects

Interfacing with other Scientific Writing group and Regulatory Affairs

Being an active participant in project team meetings

Reviewing the literature and providing summary information on various topics; providing editorial support for meeting abstracts, presentations and manuscripts.

Able to work with electronic submission systems and company Style Guides.

The Scientific Writer also has indirect supervisory responsibilities, providing technical writing guidance to staff on development reports. The writer will also work with the development report system. 

Special Skills/Abilities: Candidate must have understanding of cell culture, purification, and formulation process development and analytical methods development. Background in biologics such as monoclonal antibodies is preferred. Must also have strong written and verbal communication skills and proficiency in Microsoft Word. Knowledge of FDA regulatory requirements and ICH guidelines is desired.

Job Complexity

Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment, as well as the ability to work with individuals from multiple technical areas and with varying levels of scientific and technical expertise.


No direct reporting staff (supervision required, level of independence) 



Education: PhD degree in a scientific discipline (preferably protein biochemistry).

Experience: 2-3 years of biopharmaceutical industry experience, including 1-2 years of Scientific Writing experience. Postdoctoral experience and/or experience preparing CMC regulatory documents (i.e., INDs, BLAs, NDAs, etc.) and manuscripts is desired.

MedImmune does not accept nonsolicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall

not owe any fee to the submitting agency.


Apply online at our website at http://www.medimmune.appone.com  to position 02938- Scientific Writer.

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Comments or questions? Email Susan at caldwell@biotechink.com.