Sr. Manager/Associate Director, Medical Writing
Company: EQRx, Inc.
Posted on: February 15, 2021
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
- 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
- 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
- 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
- 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
- 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
- You can participate and work effectively on multiple
- 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
- 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
- EQuitable Medicines: Making innovative medicines
- 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
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