29 Sep
Regulatory Coordinator/Editor (Bellingham)
Washington, Bellingham 00000 Bellingham USA

Vacancy expired!

At Toolhouse, we create digital experiences for healthcare and pharmaceutical brands, in the form of websites, emails, videos, social media conversations and more. What we say and how we say it is integral to the success of our projects and our clients. We’d like you to join our team to support our medical-legal-regulatory submission and review process, and ensure we continue to produce the highest quality deliverables for our clients.

We’re looking for just the right person that can excel at both big-picture thinking and day-to-day tasks. You will be expected to create new ways of doing things to optimize our current processes, while also getting down in the weeds of a project to ensure we’re delivering 110% on even the smallest details. Our clients look to us to produce exceptional work in short timeframes, and this position is integral to making that happen.Here’s what you’ll be doing in your first year:In your first few months, you’ll learn the ins and outs of the medical-legal-regulatory (MLR) review process and the digital systems that are used to facilitate those reviews. You’ll become proficient in using those systems and ensure that all supporting details are accurately entered and complete. You will manage the lifecycle of the review process for Toolhouse, from submitting a package of materials to be reviewed, to providing all supporting details for that package, to participating in the review itself (as appropriate), to disseminating feedback or required edits resulting from the review, and ensuring that final submissions have addressed all feedback and are compliant, accurate and complete.You’ll ensure all new content (both written copy and design/layout) exceeds expectation in terms of consistency, spelling, grammar, style, clarity, completeness and accuracy prior to submission for MLR review. This includes copyediting, proofreading, and overall quality assurance, including alignment with brand style guides and the AMA Manual of Style.You’ll become the in-house expert, alongside our copywriters, for managing and properly citing all reference materials and ensuring all copy aligns with brand messaging and regulatory guidance. True fact: the FDA doesn’t inherently believe everything we have to say, so we back it up with reputable sources, such as clinical study results, peer-reviewed journal articles, FDA-approved documents, etc. You’ll manage these references and ensure that our corresponding citations and copy are thorough and accurate.You’ll work closely with key team members to optimize our MLR submission process at Toolhouse. This includes evangelizing and adhering to existing processes and best practices, as well as identifying new methods or evolving practices for continual improvement in both quality and efficiency. A core function of this position is driving adherence of internal submission and QA processes across all functional teams that contribute to the MLR submission, including Project Management, Design, Content, QA, etc.Finally, you will be an evangelist for your discipline within the Toolhouse team. You will espouse best practices and excellent quality. You need to have an eagle eye, a strong voice, and a penchant for perfection. Sweat the details.

​Have you done this before?

Do you have experience managing document quality and workflow in high-volume and regulated environments like healthcare? Do you have several years of experience editing and proofing medical and/or academic content? (You should have strong knowledge of AMA Manual of Style.) Have you you worked with teams to optimize processes around complex but routine tasks involving multiple people?If you want to talk…If you’d like this job to be your next career challenge, send us your resume along with a half-to-full page write-up describing your most relevant accomplishments and how they relate to your ability to do this job. Extensive experience as a proofreader and editor (including academic works involving detailed citations and references) and ability to excel at driving and evangelizing processes while also executing many of the tasks within the process will be some of the primary factors we consider, so make sure that shines through. If we think there could be match, we’ll get back to you to let you know about next steps.

​The where and whenThis position is open to candidates residing within Washington State. We are currently working remotely due to COVID-19 health concerns in accordance with Washington state guidance. Our team's health and safety is our number one priority. Location in Bellingham is strongly preferred when we return to the office.

This is a full-time position that we would like to start as quickly as possible. No contractors. Please do not apply if you cannot work full-time or meet the location requirements as described above. We’ll provide all of the resources you need to bring out the best in your skills and talents.

​Learn about Toolhouse

Toolhouse is a digital marketing agency, focusing on solving complex problems in innovative ways for some of the biggest healthcare companies in the world. We’re fundamentally changing how leading life science companies use technology to build meaningful connections with patients and physicians.

We are technical experts and creative artists, helping clients find their path in this new digital landscape. We fuse creativity with technology, keeping our work grounded in what matters most: people.

2020 marks our 25th year in business. We offer stability, opportunities for growth and generous benefits.

We are located in Bellingham, Washington. Our clients may all be in the big city, but we prefer our view right here. Our offices are right on Bellingham Bay, steps from the beach and close enough to watch the sea otters without leaving your desk. Nestled between the rugged Cascade mountains to the east and the San Juan islands to the west, we sit at the doorstep of endless outdoor fun. Do you like to snowboard? Sail? Shop? Bike? Run? Hike? Fish? Listen to live music? So do we. And that’s just on Wednesday. Bellingham is only 45 minutes from Mount Baker or Vancouver, BC and 90 minutes from Seattle. We work hard, we play hard and we have a great view.

Vacancy expired!


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