Director, Medical Writing
- Working from home
- Start date
- Mar 13, 2023
- Clinical, Medical Writing
- Required Education
- Bachelors Degree
- Position Type
- Full time
The Impact You’ll Make
You will be the lead Medical Writer on one or more development programs, providing both hands-on support as well as cross-functional leadership. You will also manage consultant medical writers and develop relevant Medical Writing processes. You’ll collaborate within and across departments to agree on the most important program resourcing needs, challenges and capabilities, then figure out how to get us there.
- Create, edit, and coordinate production of high-quality and timely regulatory and scientific deliverables that support multiple clinical programs covering all phases of clinical research within various therapeutic areas. Develop and maintain SOPs, style guides, and a quality control checklist.
- Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities; perform quality/peer reviews on documents developed by other writers. Act as subject matter expert for the development of data transparency deliverables.
- Communicate document deliverables needed, writing processes, and timelines to team members; negotiate with functional areas on project outcomes and deliverables to meet conflicting demands. Communicate pertinent FDA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
- Lead or contribute to improvement projects related to medical writing processes, standards, and initiatives. Lead contract medical writers and ensure that projects are appropriately resourced.
- Adhere to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs and templates.
Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to quarterly visits for routine work and departmental events.
The Team You’ll Join
The Clinical Development Team is an empowered, execution-minded group of professionals responsible for translating Recursion’s innovative science to patients. As the Director, Medical Writing, you will be an integral member of the Recursion Clinical Development Team. Reporting to the Senior Director Clinical Development, you’ll collaborate with your teammates and across departments to deliver a wide array of documents that support the expanding Recursion portfolio.
The Experience You’ll Need
- 5+ years of medical writing experience preparing regulatory documents in the pharmaceutical and/or biotech industry with at least 3 years as a medical writing project lead.
- Ability to prepare any type of clinical regulatory document (eg, protocol, CSR, IB, clinical sections of IND, CTD) according to company guidelines and international governmental regulations.
- Demonstrated understanding of clinical research, the drug development process, and US and international guidelines and regulations, eg, ICH-GCP.
- Ability to simultaneously manage multiple medical writing deliverables with aggressive timelines, balancing and prioritizing multiple parallel work streams to meet project goals; flexible and does best work in an energizing environment; embraces new technology to meet business needs.
- Ability to work with cross-functional teams to complete medical writing deliverables within predefined timelines.
- Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs
How You’ll be Supported
- Regular 1:1s with your supervisor provides opportunities for support and feedback.
- Transition and resourcing plan
- Membership to medical writing or Regulatory organization (AMWA, EMWA, DIA Medical Writing, RAPS)
The Values That We Hope You Share:
- We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
- We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
- We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.
- Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
- We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.
Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.
More About Recursion
Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City.Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today.
Recursion is proudly headquartered in Salt Lake City, Utah with offices in Toronto, Montreal and Milpitas, California. We're working to solve some of the most meaningful problems facing human health today. Come do the most impactful work of your career at a company that prioritizes belonging, collaboration and career development.
41 S. Rio Grande Street
Salt Lake City
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