Sr. Manager/Associate Director, Medical Writing

Company: EQRx, Inc.
Location: Cambridge
Posted on: February 15, 2021

Job Description:

Sr. Manager/Associate Director, Medical Writing Rx Development Cambridge, Massachusetts, United, States Full-Time We are creating a truly modern drug development, launch and supply process, incorporating innovation throughout, which can have a meaningful impact on speed and cost without compromise. Patients deserve affordable, high-quality medicines they can trust. Daniel Hoey Chief of Technical Operations 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 prepare, edit, and finalize clinical protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, manuscripts in addition to other core medical writing deliverables. You contribute to identifying key document messages and supporting data. You will partner with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents. You will work closely with the study team to ensure that results and messages in clinical documents accurately reflect the underlying data and key information sources. You will collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents. You will manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. You will ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables and work closely with the study team to reach consensus on timelines for deliverables. The Impact You Will Have

• This is not your standard Medical Writing position.--EQRx is on a mission to Remaking Medicine and this role is critical to our success. This position is a highly visible role that will help us drive forward towards our pinnacle goal of truly putting patients first. Your Superpowers
  • You have a Masters or PhD in a life-sciences field (e.g. Medical, Biology, Biochemistry, Molecular Biology or other relevant scientific or clinical discipline).--
  • You have advanced clinical regulatory document writing and review skills.
  • You have a demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., International Council for Harmonisation and Good Clinical Practice.
  • You have a strong interest and experience in exploring new technologies related to documentation and efficiency.
  • You have a strong understanding of relevant scientific and medical terminology and statistical methods.
  • You have experience with policy, guidance, and procedure development and maintenance.
  • You have global experience and have driven new system adoption.
  • You demonstrate the ability to analyze existing processes and implement effective changes as needed.
  • You have Oncology and immuno-inflammatory experience.
  • You can coordinate the ongoing evaluation of products technologies, services, and processes.
  • You can identify opportunities to reduce costs and improve timelines.
  • You are constantly reviewing publications and information sources to keep updated on current regulations, practices, procedures and proposals.
  • You monitor industry best practices, changes in global regulations and guidelines and recommend changes and upgrades to existing policies, SOPs and systems.
  • You have a working knowledge of International Council for Harmonisation and Good Clinical Practice guidelines and in-depth knowledge of clinical research processes, regulation and methodology.
  • 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. 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. The Disruptor Are you ready to make waves in the industry and change the tides?
    • EQuality Medicines: Equally good or better, innovative medicines
    • EQuitable Medicines: Making innovative medicines affordable
    • EQual Access: Sustainable, frictionless access for people to cutting-edge medicines We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel we are definitely not for you. Want to build the wheel? We might be just what you are looking for. EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. 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. Find Your Professional
          SuperpowerWhat's yours? Find the right job for your skills. Stay in the Loop Get Job Alerts Follow on social. Stay connected on Glassdoor, Instagram, Twitter & LinkedIn!
          • 50 Hampshire Street
            Cambridge, MA 02139
            (617) 315-2255 Two-hour street parking is available. There are also several parking garages in the surrounding area.

Keywords: EQRx, Inc., Cambridge , Sr. Manager/Associate Director, Medical Writing, Executive , Cambridge, Massachusetts