February 19, 2021

[FREE WEBINAR] Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data

Get a copy of the slides from this webinar or click to watch the recording.

A comprehensive scientific communications program is a critical tool for medical device, in vitro diagnostic and pharma companies to raise market awareness for their products.  Done well, effective “real-world” communication can position your company as a key scientific leader in its field and drive market adoption and sales.  However, ineffective or poorly executed scientific communications can result in lost opportunities to make an early, meaningful and even a positive impact on the market.  

In this practical presentation, President Laurie Mitchell: 1) discusses how an effective scientific communication plan is an important marketing tool for an organization, and 2) presents five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data.  Watch to learn how this applies to your organization and how to implement these strategies into your current processes.

Sign up for future webinars here.

Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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June 4, 2019

Resume Tips from a Medical Writer Hiring Manager

Author: Ashley Self

I’m staring at a large pile of medical writing resumes on my desk. Is yours in it? Can I tell from one glance whether you are a good candidate for the position? Will the format and content of your resume make me want to read the entire thing?

If you dread updating your medical writing resume or CV, you are not alone. Of all the critical documents you produce, this is one that requires the perfect balance of accuracy, brevity and noteworthiness. There are a lot of ideas and tactics for making your resume shine, and that can make it easy to go overboard. What I am looking for is a true representation of your experience and skills. I can discern between facts and embellishments, and I prefer facts, even if that means your resume is a little shorter than other examples you may be trying to follow. Your transparency also helps me place you in a position where you will thrive, ensuring what will hopefully be a long-term relationship. (Note: honesty and transparency are equally valued during the interview phase.)

Crafting a resume that stands out can be difficult, but it is well worth the effort. And you can start by doing the following:

Nailing the First Impression

Let’s be honest. I skim through the resume pile. Therefore, it’s very important that you highlight relevant information and format your document to make that information easy to find. The order in which you list your experience and expertise will vary depending on your background (read Resume 101 below). What’s more important is how you present it.

Resume 101

Basics   Every resume should include the basics: summary, professional experience, education, skills, specializations, certifications, and published works. If you are just starting off in your career and have more education than experience, it’s OK to highlight your skills and education first. To flesh out a resume early in your career, list specific coursework and projects you worked on during your education.

Keywords   If you are applying for a job described as: medical writer with experience with CER writing, FDA regulatory approval guidelines and MDR guidances in the medical device field, the key parts of your resume should feature those keywords. The keywords should appear naturally within your summary and professional experience, rather than seem

Customizing   Ideally, you will customize your resume for each job you apply to. This will allow you to tweak your summary, keywords and bold/highlighted type to appeal to the specifics of the particular position.

Continuity   The experience and expertise listed in your resume should match whatever you have listed online on your personal website, LinkedIn profile and other professional profiles.

Format   Use only the most basic formatting tools on your resume. That will ensure that it can be read properly by automated scanning software (if the company you are applying to uses it). If file format is not specified, it’s best to submit your resume as a PDF, as a PDF is static and can be read by almost anyone without shifts in formatting. Within the body of your resume, you can use varying font sizes, all caps, and bold to call out each section, and even horizontal and vertical lines and indents to help organize the information. The rest—such as color blocks, graphics and playful fonts—is best left for more creative presentations. Consistency in style and simplicity in design are key. The proper use of formatting is also a chance to show off these valuable skills to your employer.

Applications   While it sounds a little old fashioned, most hiring managers in the medical regulatory field want to know that you have experience working with complicated Microsoft Word and Excel templates and formatting.

Proofread   If you aren’t an amazing proofreader, ask someone else to look over your resume before you submit it. One trick I like to do is copy and paste the text into a new document and then change and/or enlarge the font and re-read the text. That can help you locate small mistakes you may have missed.

A Quick Note About Recruiters   Any recruiter inquiry should be treated with the respect and professionalism you would give your potential supervisor. Often recruiters aren’t as familiar with the details of the position or as knowledgeable about the field of work as the employer would be. This can be misleading to candidates who incorrectly assume the position isn’t worth pursuing. Dismissing a recruiter’s request could cost you a great opportunity.

Your resume layout doesn’t have to be fancy. It should be simple and easy to read, with a clear delineation between sections. Don’t be afraid to use bold type, bullet points and sub-headings to highlight work experience and expertise that is directly related to the job you are applying for. This will draw my eye and make scanning much more efficient. Just be wise about what you highlight; a few words within each block will suffice.

A brief but rich summary statement at the beginning of the resume is also a great place to let me know exactly what I might find interesting within your resume body. Here, again, if your experience is extensive, you can follow the summary with a bulleted list of relevant specifics.

For example:

Summary: I have over 20 years of experience bringing large and small medical device manufacturers into regulatory compliance in five countries. I’ve supervised clinical trials and managed data collection, quality control and labeling to help several manufacturers meet global regulatory guidelines.

  • X subject matter expert • CE marking and UDI compliance experience
  • Project and team management • RIMS design and implementation

Finally, if your work experience is comprehensive, you can provide a short summary of career highlights to call out specific accomplishments as an introduction to your professional experience section.

The keyword here is “specific.” These sections must be succinct, and should include details, not generalizations.

Demonstrate Your Own State of the Art

Now that you have caught my eye, use the professional experience and education sections to back up your claims. Match the text you have called out in your summary section within each job description and highlight accomplishments in addition to outlining your duties. Be specific: instead of “responsible for regulatory compliance for all products” try “brought 25 legacy and 12 new products into compliance with new MDR guidelines.”

If you have many years of experience, your resume may be quite long. In that case, feel free to provide a separate document highlighting your relevant experience and accomplishments relating to a specific skill (e.g., a list of all the CERs you have prepared, details on regulatory statements you managed for a specific device category, etc.)

Similarly, a separate page with links to published work or accolades is better than listing those within the body of the resume where they may get lost.

If your resume is short, it’s OK to highlight your specific skills. Accuracy, the ability to work with a team, the ability to meet deadlines, problem solving in a crisis, etc. are all great skills in medical regulatory writing. If you don’t have an abundance of professional experience, but you worked on a project where these skills stood out, be sure to mention it.


Not all of us have a “door busting” resume with five pages of extensive industry experience. And that’s OK, as long as you are applying for a job that is appropriate for your level of experience. The golden rule is to present your actual skills in a way that is attractive and easy to understand. That alone demonstrates a proficiency that is important to all medical writing hiring managers: the ability to organize data and information in a clear and concise way. And that’s something I will never undervalue.

Once you have completed your resume, the next step is to get your name out there: Successful Networking in Two Easy Steps

Is your resume ready to get out in the market? Are you ready to apply? Check out our Careers page.

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April 16, 2019

Successful Networking in 2 Easy Steps

Author: Ashley Self

When you work as a freelance medical writer, it’s easy to feel isolated. You likely work alone, and the nature of your work requires intense focus. And that’s fine…while you are working. But what about when you are looking for your next project? Or, if you are new to the medical writing field? The solitude that serves you so well while you are writing doesn’t foster a great network of colleagues, mentors, and potential employers—and it’s this network that helps push your career forward, expand your knowledge and refer you to new work opportunities.

According to market insights, several segments of the global healthcare regulatory affairs outsourcing market are projected to increase on average more than 13% annually between 2017-2025. Use the following networking tips to ensure you have a share of this growing market moving forward. 

Step 1: Make Yourself Easy To Find

Building and maintaining your online identity or personal brand may not feel like networking, but it forms the main touchpoint for all your future networking efforts.

Build a personal website

With the availability of easy-to-use website building platforms, anyone can have a professional, well-designed website live in a matter of hours. Be sure to use your full name and keywords (like medical writing, CER writing, medical regulatory writing, as well as listing your areas of specialization) on your home page. You can use the other pages to feature links to work samples, testimonials or a list of companies you have worked with, a detailed bio of your experience and education, and even a blog that you update periodically (regular, keyword-optimized updates to your website make it more likely to be found in online search queries). Do an online search and review the websites of other medical writers to see what works.

Fill in the details of your online profiles

Simply having a LinkedIn or other professional networking profile isn’t always enough. According to Undercover Recruiter, including a professional headshot; writing a comprehensive, keyword-optimized headline and summary; and including specific keywords in your job history and skills overview may give your profile an edge.

Clean up your social media profiles

Most employers do a Google search of a prospective candidate’s name before they hire. Have you Googled your name? Now is a good time to find out what hiring managers might see. It is also wise to keep separate social media accounts for your personal and professional endeavors. Check the privacy settings of your personal accounts to make sure you are only sharing that information with trusted friends, not the general public. For your business social media profiles, use a professional profile photo and make sure your posts represent you as a job candidate.

Create a weekly blog

Finding time to write a blog in addition to working full time might sound like a stretch. But blogging can offer benefits that static websites and online profiles don’t—regularly updated content that can be found by search engines. Your weekly blog post doesn’t need to be a four-page research paper about the specifics of a new medical procedure. It can be a short five to ten paragraphs about something new in the industry that you find interesting. Just be sure to include keywords in the blog title and body. 

If you’re enjoying this read so far, get some insider tips on getting a hiring manager to pick your resume.

Step 2: Network Online and in Real Life

Now that you have a comprehensive online identity, it’s time to start making connections. 

Start with social media  

Most people find online networking less intimidating than networking in person. That makes it a great place to start. According to a Harvard Business Review article by Doug Camplejohn, VP of Product Management at LinkedIn, the best practices of online networking are:

  1. Focus your inquiries on your peers, rather than upper management. While upper management has the most sway, they may not have the time to reply. Fostering relationships with your peers will ensure you have a nice network of colleagues that grow with you as you move up.
  2. Be brief and try to find a common ground. Maybe a peer shared an interesting article or studied at the same school as you. These make for nice icebreakers and set you apart.
  3. Ask a question rather than make a pitch. Inquiring what path led someone to their current position is a nice way to spark up a conversation, particularly if you are looking for a mentor. Save the pitch for later in the conversation.

Follow us on LinkedIn and Twitter to get more tips on better management of your online presence.

Join online groups and organizations

There are several regional and international associations dedicated to the medical regulatory and writing industry. Most of them boast thousands of members and offer valuable training resources and industry updates. Once you join, try to find members in or near your geographic location. As a freelancer, much of your work may originate in a city far away, however, it’s still nice to have local contacts. Similar to making contacts via social media, you can comment on other users’ posts to introduce yourself, or generate a post of your own. Maybe ask a Word formatting question or initiate a discussion on best quality control practices—something that is relevant to your work but doesn’t cover subject matter people might be uncomfortable discussing publicly online. Alternatively, you can share an article you found interesting. Finding and joining active groups on LinkedIn is also recommended. Below is a list of well-respected organizations:

Attend conferences   

The above organizations host annual conferences that are attended by most major players in the industry. Now that you have a handful of online contacts, make a plan to attend a conference together or meet up at their booth. A couple of weeks before the conference is also a great time to ping organizations you are interested in working with to see if you can set up a specific time to meet with them during the conference to learn about their needs. Bring several copies of your business card and a short (half or full page) bio that includes a photo and your most relevant experience and training.

The Net Gains of Networking

Networking is usually a slow process. Think of it as forming a friendship. Friendships offer value to both parties and your networking efforts should do the same. Once a relationship has formed, foster it through regular contact. You can share some wonderful tips that have worked for you. Or maybe reach out for some advice on how to handle a complicated data set. Finally, when you move up the chain and you receive a query from a newbie writer, remember to offer them the same kindness you received all those years ago and give them a hand up.

We are constantly sharing information to keep you updated with the regulatory landscape, and to keep you connected. Follow us on LinkedIn and Twitter.

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April 9, 2019

How the Best Medical Writers Master Quality Control

Author: Ashley Self

As a medical writer you juggle huge, complicated data sets from hundreds of source studies, analyze that data to draw conclusions and ensure all your processes meet regulatory guidelines. You simply remember all that information, right? Also, you’re perfect. You’ve never pasted a series of data into the wrong cell or misplaced a decimal point. Especially not after working ten hours straight to meet a deadline.

What’s that? You’re human?

Join the club. It’s only reasonable to anticipate an occasional error from a medical writer who is tasked with researching, analyzing, processing, and inputting large volumes of data and information. That’s why the best medical writing teams have built quality control protocols into their processes, starting from the beginning.

That’s right. Good quality control isn’t just proofing the final document before it’s submitted. It’s an ongoing process. Implementing the following best practices is the first step in a robust quality control plan.

Start with Templates

Working from document templates is a great way to save time and ensure formatting, naming conventions and document style guidelines remain uniform in a large document. (Have MS Word do the work for you) Templates allow you, the writer, to stick to content rather than constantly having to pull up formatting tools to make adjustments as you write. When the time comes for a final quality control proof, documents created from a template typically have fewer formatting corrections and also take much less time to review. As an added bonus, working from a template can also ensure that the document will translate into the final submission format without errors.

Stop and Review

Medical writing teams should also practice a “review as you go” approach to data extraction and writing. When adding a new data set to the document, comparing that data to the source data before moving on to the next section doesn’t take much time and can catch costly mistakes early. 

To make these early interventions run smoothly, new writers should be trained on how to properly use document templates and how to run mini quality control checks throughout the writing process. 

The Final Step

Even with the above protocols, in the end, a comprehensive quality control review by an independent quality control specialist is mandatory. This quality control specialist should have specific training on how to effectively review the final document based on general best practices and internal guidelines. During this final review, the reviewer will check all data against the data source; confirm that conclusions and findings are supported by the data; check for formatting, grammatical and style errors; verify all internal and external links and references; and confirm the content and structure meets regulatory guidelines.

Get a free copy of the quality control checklist

At this critical stage, it is important to maintain an audit trail of all changes and corrections recommended by the quality control reviewer. In addition to noting these changes through a tracking feature in the software, the reviewer should note major content issues in a separate report. As the original writer, you must then go through the final document and make the changes. If there is a major error you think was noted by mistake, you can explain your reasoning in the quality control report. When any major changes are made, you must also remember to review the related conclusions to confirm the data still verifies. At this point, any dynamic links within the document should also be broken.

While a quality control reviewer’s job may seem small compared to the medical writer’s, reviewing a document that is several hundred pages long and full of thousands of data points is a painstaking process. This is not something that can be dropped in their inbox a few hours before your deadline. Quality control review should be scheduled in your original project scope. After all, the quality control review ultimately upholds your stellar reputation and keeps all your hard work from being invalidated because of a small error.

Worried you may miss something? Download our Free Quality Control Checklist.

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March 25, 2019

6 Project Management Secrets Used by Top Medical Writers

Author: Ashley Self

I bet when you became a medical writer, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers, you’re not alone.

2017 Project Management Institute study found most project management initiatives fail for a handful of reasons: 37% fail due to a lack of clearly defined and/or achievable milestones and objectives to measure progress, 19% break down because of poor communication and, similarly, 18% fail due to lack of communication by senior management. While no project can be made absolutely foolproof, seasoned medical writers have learned to rely on advance planning and adherence to certain basic guidelines to ensure their projects run smoothly.

For your next project, once the project liaison has met with stakeholders to nail down the scope and budget, use these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements.

1. Create and stick to a detailed project matrix.

Tempted to throw your project calendar out the window after a series of missed deadlines? Consider using a comprehensive project scope and calendar matrix. The matrix should be the product of a detailed meeting with the project stakeholders and leads on both sides, and highlight who is in charge of what deliverables, who is responsible for signing off on that material, and clear deadlines for each. Each section of the matrix should call out not just final due dates from the writers, but also how long the principals have to review submitted sections and how long it should take to make final revisions. 

It takes quite a bit of work just to build a matrix that will cover the extensive information required for most medical writing projects, and, as you know, things come up during any project that require flexibility and reworking of the matrix: new data is released and has to be worked in, other data is held up in final review, a principal plans a vacation when they were scheduled to review their section, etc. Therefore, in addition to the matrix, you should also have contingency plans in place for when things go awry.

2. Communicate.

As a lead writer on a large project, you likely manage multiple writers and also interface with a principal contact on the stakeholder side, or, in some cases, the stakeholders themselves. Having the ability to communicate effectively with both is a valued skill.

Communications with stakeholder representatives should be kept to a minimum. Unless there is an urgent issue that will substantially affect sensitive project timelines, batch any news or concerns into periodic updates. Sensitive issues should be handled over the phone.

Within your own team, clear, detailed communication is key for keeping the project running smoothly. Create an internal email group or chat platform for each project so that those writers are privy to all project-related correspondence. 

For communications with both stakeholders and internal writing teams, taking the time to generate a file of email templates prepared for various scenarios will streamline your communication process and ensure key questions/points aren’t inadvertently left out in the heat of the moment. Make the email subject lines very clear and don’t be afraid to call out that an RSVP is required urgently. To make the body of the email skimmable, write a short summary of what the email requires and use bullet points and bold text to highlight key points.

Finally, don’t be afraid to pick up the phone. Sometimes a quick call can subvert a lengthy email exchange.

3. Customized document/version management.

There are two ways to manage changes and updates to large medical regulatory documents: use/update one dedicated document and reconcile changes manually or via the application’s automated tools; or, use a secure, cloud-based application that allows changes from multiple sources in real time. Either way, sufficient time must be spent ensuring all changes were made correctly, and also that the changes did not upset the document’s formatting. When reviewing changes to a section using a tracking feature, be sure and do a final review of the section with all the highlights turned off to make sure the formatting hasn’t shifted, and verify that the sentence structure is in tact.

4. Build-in writer training.

One of the lead writer’s lesser-known skills is new writer training.Certainly, you don’t have substantial time to sit down with each new writer as they come on board and walk them through basic SOPs. A database of graduated training materials can get new writers up to speed on company processes, style-sheets, use of document templates, and other standard procedures. That leaves more time for you to give new writers valuable feedback and answer specific questions as they are introduced to new projects. 

5. Streamline quality control with style sheets.

Proofing and fact checking a near 300-page document can be arduous, and, in fact, most lead writers report spending a large percentage of their time on the task. While there’s no real way to speed up a read-through of the entire document, checking the document against a predetermined style sheet can make locating errors in naming conventions, broken formatting, and missed template fields much quicker. Using the “Find” command for red-flagged terms and template <<field>> terms can help you catch many things before you even begin the proofing process. A style sheet can also call out known areas of concern so that writers can review those sections more effectively.

While this process can be time consuming, it reflects well on your company’s reputation to submit documents for stakeholder review with these errors resolved.

6. Post-project review.

The best time to identify holes in your workflow is right after a project is completed. Budget in the time for a sit down (or web conference) with your principal and your writers and download all that went right or wrong with the project. This may seem redundant, but it is a step that will inform the schedules/planning of future projects and also help you build contingencies based on real scenarios while they are still fresh.

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For more regulatory writing strategies, download our 10 Strategies to Build Efficiencies in Your Regulatory Writing Processes

Criterion Edge (CE) employs top talent in the regulatory business to deliver high quality medical/regulatory writing and clinical safety services to the pharmaceutical and medical device industries. Members of the CE team enjoy support from our project managers, support staff, and ongoing training programs to keep them up-to-date on the latest regulatory guidelines. Interested in being a part of our team? Check out our current openings.

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