Senior Principal Medical Writer

INTEGRATED NEUROSCIENCE • Marshfield, WI • 6d ago

JOB REQUIREMENTS: Senior Principal Medical Writer - Regulatory -
Oncology - Single Sponsor Syneos Health is a leading fully integrated
biopharmaceutical solutions organization built to accelerate customer
success. We translate unique clinical, medical affairs and commercial
insights into outcomes to address modern market realities. Our Clinical
Development model brings the customer and the patient to the center of
everything that we do. We are continuously looking for ways to simplify
and streamline our work to not only make Syneos Health easier to work
with, but to make us easier to work for. Whether you join us in a
Functional Service Provider partnership or a Full-Service environment,
you\'ll collaborate with passionate problem solvers, innovating as a
team to help our customers achieve their goals. We are agile and driven
to accelerate the delivery of therapies, because we are passionate to
change lives. Discover what our 29,000 employees, across 110 countries
already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are
passionate about developing our people, through career development and
progression; supportive and engaged line management; technical and
therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically
be yourself. Our Total Self culture is what unites us globally, and we
are dedicated to taking care of our people. We are continuously building
the company we all want to work for and our customers want to work with.
Why? Because when we bring together diversity of thoughts, backgrounds,
cultures, and perspectives - we\'re able to create a place where
everyone feels like they belong. Job Responsibilities Develop regulatory
documents for submission to regulatory agencies globally, in accordance
with ICH and other global guidelines, standards and processes, and
Incyte authoring standards, as applicable, in adherence with
study/project timelines and corporate objectives. Manage medical writing
projects, including developing timelines (working with the study/project
teams, as necessary) and communication with cross-functional team
members to maintain awareness of review cycles and expectations.
Participate in cross-functional meetings to provide input regarding
medical writing deliverables, timelines, and any process(es) needed for
the completion of regulatory documents. Review other documents
associated with the assigned project(s) (eg, Protocols and Statistical
Analysis Plans), as appropriate. Participate in cross-functional process
improvement initiatives. Participate in defining and writing standard
operating procedures and best practices for an efficient preparation of
quality documents. Manage internal and contract medical writing
resources as required to ensure timely completion of assigned projects.
Mentor more junior medical writing staff. At Syneos Health, we believe
in providing... For full info follow application link. ***
APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/B37AED3D26F74427

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