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.

Conclusion

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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May 9, 2019

Are You a Global Medical Device Manufacturer That Is Tired Of Multiple Regulatory Audits? Consider Transitioning To The MDSAP Single Audit

Author: Dr. Suzanne Broussard

MDSAP as a Single Regulatory Audit 

The Medical Device Single Audit Program (MDSAP) is now in year three of voluntarily allowing medical device manufacturers to satisfy requirements of multiple regulatory jurisdictions with a single audit. Understanding the basics of MDSAP is the first step to determining if this is right for your organization.  

Device manufacturers are starting to accept this more harmonized auditing program, with over 2,700 manufacturers having undergone an MDSAP audit as of December 2018 (Figure 1). The significant increase in audits in 2018 reflects Health Canada’s hard deadline of January 1, 2019 for device manufacturers to comply with MDSAP in order to sell medical devices in Canada. While there were plenty of concerns about the transition, Health Canada received over 3,000 MDSAP certifications or transition submissions accounting for 90% of medical manufacturers operating in Canada. The remaining 10% are companies with very low or no sales, meaning they may likely pull out of the market.  

Several early adaptors are lauding the MDSAP program for saving time and limiting company resources needed for auditing agencies. These outcomes are in line with IMDRF’s primary goals for creating MDSAP, which are to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”  

If you are one of the many medical devices manufacturers that have not yet embraced MDSAP, industry experts suggest it is time to get started! This single audit via MDSAP provides an opportunity for companies to reap the benefits of reduced audits from agencies in multiple jurisdictions if they sell products in participating countries. 

Keep in mind that MDSAP does not place a single new requirement on device manufacturers. What MDSAP does is place requirements on the Auditing Organizations (AOs) dictating how to consistently perform an audit. Essentially, AOs are approved by regulatory agencies to perform audits after a rigorous process to prove competency. These AOs are charged with performing the audit in a manner that is consistent and predictable while giving a high degree of confidence that the manufacturer is in complete compliance.   

Participating Countries in MDSP
Participating Countries in MDSAP

FDA Touts the Benefits of MDSAP 

Even regulatory authorities like the FDA are promoting the many benefits of MDSAP. 

  • MDSAP routine audits are announced in advance by the scheduling AO and have a pre-established duration. 
  • Manufacturers have one full month to respond to AOs for critical nonconformities (grade 4 and 5) compared to only 15 working days after an FDA inspection. 
  • MDSAP Certification documents may provide a marketing advantage. 

Is Your Organization Ready to Transition to MDSAP?  

Some companies that have gone through the process claim that they found the process easier than going through an FDA audit once they embraced MDSAP. Why? Because, the MDSAP audit is performed in a specific order that is predictable and clearly outlined. This approach is very different than an FDA or ISO audit, which are much less predictable. Company testimonials on the FDA MDSAP site claim transition to MDSAP save costs internally with less disruption.  This sentiment is shared by other industry leaders who applaud the prescriptive nature of the MDSAP audits. 

There are no surprises at MDSAP audits  

IMDRF provides device manufacturers with everything required to understand and prepare for MDSAP. A plethora of resources that explain the program in more detail and help prepare for an MDSAP audit are available on FDA’s website. Best of all—they are free! 

The most helpful resources are the MDSAP Companion Document and the MDSAP Audit Model.  

  • Both these forms provide detailed information that directly corresponds with the MDSAP audit.  
  • There is a section in the documents to explain what should happen at each step of the audit.
  • Requirements are asked by auditors in the order presented and the flow does not vary allowing the manufacturer to better plan the audit.  

If your organization sells medical devices in multiple participating countries and already maintains a high level of compliance, transitioning to MDSAP is worth considering.  Are you ready to ace the MDSAP?

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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 a MarketWatch report, 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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April 2, 2019

9 Simple and Essential Microsoft Word Tools For Successful CER Writing

Author: Katherine Lalicker, Editor: Ashley Self

Managing your figures, tables, references, and so much more on a lengthy, complex regulatory document can seem impossible. Even seasoned medical writers struggle when trying to make changes or add content without breaking a document. Chances are, the tools you need already exist. Read on to find out how some of the simplest Microsoft Word tools can allow for smooth changes to maintain an organized, uniform document.  

Copy and Paste

CER documents need to be clear and uniform, which can make it difficult to pull content from one document to another without disturbing the style of the document. There are multiple paste options that allow you to either match the formatting of your document or paste text without any formatting. All options can be found under the Home tab on the toolbar in the copy and paste section. Two important functions for CER writing are Match Formatting and Keep Text Only

  • Match Formatting: Text is formatted to document content. 
  • Keep Text Only: All text formatting, including hyperlinks, are removed. This is useful when you want to remove all hyperlinks simultaneously. 
Templates

A well-designed template functions as a formatting blueprint for your document. While some companies may provide their own template, it is important to be able to create and establish a template to ensure uniformity through your work. With a good template, writers just need to insert the information.

Preset styles found in the Styles section of the Home tab help writers focus on content and quality. Found under the Styles Pane, styles can be quickly modified to match the formatting guidelines for your document. Once a style has been added, it will appear on the styles pane where you can select them when needed.

Styles Pane

Additional features such as an automatic table of contents and cross-referencing can also be added to a template. 

Useful Tip: You can save your formatting as a template by selecting File – Save As Template.   

Useful Tip: Formatting is a meticulous aspect of any complex document. To reveal formatting, click on the paragraph mark located on the Home tab and all formatting marks appear. This tool makes it easier to edit the formatting without losing content.  

Table of Contents 

In large, information-dense documents, it is counterproductive to scroll endlessly to find sections of interest. A well-done table of contents in MS Word makes finding specific content simple. This creates a link between corresponding titles in a table of contents instead of requiring a user to manually insert a cross-reference for each section. A table of contents is easy to insert, but users make some common mistakes that can affect the efficiency of the automated tool. 

Formatting styles are critical to creating a table of contents. Word provides preset automated table of contents options that require you to pick a style for each of your title types. You will notice that “Heading 1,” “Heading 2,” and “Heading 3” are located where the chapter titles and sections will be. Applying the corresponding styles, located in the Styles section, will determine the format of your table and which titles are linked. 

TOC
Table of Contents

Decide what text you want to be included on the Table of Contents and use either Heading 1, 2, or 3 – Go to ReferencesTable of Contentson the left side of the ribbon – Choose from the Automated Table of Contents options that are previewed

As a good practice, the table of contents must always be updated at the end of the writing process. Updating the entire table will revise heading changes along with page numbers. 

You can modify your table of contents by selecting the Custom Table of Contents option. Changes can be made to the table format and what you want to be included on the table in the dialogue box. 

Cross-referencing connects items within a document, similar to a hyperlink, for smooth navigation, which is useful in lengthy documents. You want to use this to ensure the reader can access information quickly without needing to manually search for it. The cross-reference tool can be used to link headings, footnotes, captions, figures, and tables to where they are in the text. Did you know that cross-references can be updated just like the table of contents? Updating is crucial because content is constantly moving around the document from page to page.

To insert a cross-reference, go under the Insert or Reference tabs, and choose the type and caption.  

Insert tab: Insert – Link – Cross-reference

References tab: ReferencesCross-reference

An added benefit to using cross-reference is that it will actively change based on the output. If a document is printed, the cross-reference will change to tell the reader where the content is in printed form.  

Some writers recommend this book, Microsoft Word for Medical and Technical Writers, as a good read to familiarize yourself with all that MS Word can do for complex medical writing needs.

Tables

When pulling tables from PDF documents onto a Word file, a simple copy and paste doesn’t always do the job, requiring the writer to recreate the table. These tables can include important information on instructions, uses of the product, and complex clinical data. 

Once you insert a table, use the table Design and Layout tabs to quickly customize a table. The preset styles are a good place to start and can be altered by selecting the menu under Modify Table Style. A modified style can then be saved so it is available anytime you need it.     

Table Properties

A split table can cause confusion, especially when a large amount of information is being presented. To resolve this, we can go under the Table Properties and select Repeat as header row at the top of each page to make sure the headings of the table show up if a large table splits across pages. Additionally, by unchecking the box for Allow row to break across pages, you can also prevent a row from splitting up.

Headers and Footers 

It is common for a company to want their logo and additional information included on the top and/or bottom of a document’s pages. Headers and footers are integral to any document for this reason and include features that can make editing them easy.  

Once you have opened the header and footer edit option, either by double clicking one or choosing the option to insert one, the Design tab appears. Here you can choose style, formatting, and content you want to be included in your header and footer. 

  • Adding a Logo: The easiest way to add a company’s logo is to select Picture From File. Once you have chosen an image, you can edit it the same way you would in the body of the document. A large image will automatically adjust the header or footer length. 
  • Date & Time: This option allows you to automatically add the date and time with multiple format choices.
  • Text Location: Users have the option to place text in the center, the left, and/or the right of a header and footer. This is useful if you have multiple sets of information you need to include in one space. 

Headers and footers, like page numbers, can be excluded from the first page. 

Page Numbers

Including page numbers is critical in any long document, but there are other benefits to using them in technical writing. Page numbers can be used in cross-referencing when the text is referring to information found on a specific page. Page numbers can also be modified to fit the needs, and style, of your document. 

By default, a number will always appear. However, you can unmark the box that reads Show number on first page when you are first inserting page numbers. This will turn the second page into “page one” of the document, a useful tool for when you have a cover page. 

Tracking Changes 

Many people will likely be reviewing your document, which is why the ability to track each user’s activity on a long document is so important. Word provides tools for tracking changes, edits, and comments. These tools are useful when one or more people are reviewing/editing a document. All of this can be done under the Review tab.

Track Changes
Track Changes

Changes can be tracked by clicking the Tracking menu – turn on Track Changes. Comments can be inserted by selecting New Comment.

All changes and comments will appear on the side of the page and indicate what has been changed in the document and comments that have been made. 

Useful Tip: The Navigation Pane makes it easy to view changes and comments. In addition, it includes a tab where you can view your table of contents and click through it without needing to scroll back the top of the document. The Navigation Pane can be made visible under the View tab. 

Page Orientations 
Section Break
Section Break

Clinical Evaluation Reports (CERs) often include figures and tables that do not always fit on a regular, portrait-oriented page. Page orientations can be found in the Layout tab. If you have a table or figure that is too wide for one page, it is possible to change the orientation of that single page to Landscape.

  • Go to the Layout tab – Click on the Breaks menu – Select Next Page under Section Breaks (this is not the same as a page break) – Select Landscape under Orientation
  • Once you are finished, you can insert another section break and return the orientation of the following page to portrait. 

Adjusting the orientation to fit specific content saves time and ensures you do not need to alter or potentially lose important information.


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RAPS Regulatory Convergence 2019

September 21-24, 2019

Philadelphia, PA

Register today to examine regulatory challenges and solutions with top industry professionals.

Book a consultation with us! President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #349. 

Stop by for exclusive assets, tips, or to discuss regulatory or medical writing projects. And while you’re there… sign up for the chance to win a FREE Amazon Echo!