Director, Document Management
EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.
What You'll Do
You will lead a team of documentation specialists and manage all aspects of clinical document control. You will manage and create an organized environment for easy and efficient access to all documents and administer the centralized electronic working files for our clinical departments. You will work closely with colleagues across other departments to ensure timely completion and submission of all necessary documentation by each key person. You will act as a critical point of contact for retrieval of specific documentation and you will be our go-to person for up-to-date regulatory requirements for documentation. You will act swiftly to implement changes, if necessary.
You will implement document storage systems to optimize efficiency. This role will provide analysis of data submitted via documentation and compile critical reports, as needed. You will develop and manage strategies for long-term storage of key information and protection of data, and you will participate in internal audits and external regulatory inspections. You will provide documentation training training and revise outdated documents for consistency and accuracy. This role will perform document control functions and maintenance and create documentation that meets the regulatory requirements before distributing through the company to implement. You will support all audits and perform document formatting for both paper and eCTD submissions.
You will provide support to the Regulatory Submissions Team and ensure relevant regulatory-authority compliant document naming conventions are applied to components. You will assist in the bookmarking, hyperlinking and quality control checking of electronic files for eCTD submissions. You will import and create documents for regulatory submissions including referenced literature and reference lists.
The Impact You Will Have
This is not your standard Director of Document Management position. We are doing things different here than how it is normally done, and this role is no exception. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.
Who You Are
- You have a bachelor’s degree.
- You have a minimum of 5 years of pharmaceutical industry experience related to clinical document management.
- You have familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices.
- You are current in your awareness of regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive).
- You possess a thorough knowledge of electronic TMF applications and DIA reference models.
- You can participate and work effectively on multiple cross-functional teams.
- You play well in the sandbox. You understand relationships are key and have strong interpersonal skills.
- You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.
- You can thrive in a smaller company environment and love the pace of a true startup.
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Are you bold enough?
Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.
We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities. What does EQRx stand for?
Are you ready to think differently and embrace the journey?
It’s (mutually) beneficial.
You’re curious about what sets us apart from the rest. What do you get from working at EQRx?
So, let’s start big—working at EQRx means having the opportunity to change the world.
By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:
- Working with the smartest game-changers in the industry
- Cutting down the red tape of “the way things are done”
- Seeing and feeling the daily impact of your work
- Growing as a professional and a person
- Committing to neverending social responsibility
And, yes—we also have a killer list of things that’ll help you shine as part of the team.
But to us, these are just table stakes.
- 100% Medical, Dental, and Vision coverage
- Flexible Spending Account
- Health Reimbursement Account
- Free snacks and drinks
*As EQRx grows, please note that some of these are subject to change.
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Cambridge, MA 02139