Principal Medical Writer
Company: Johnson & Johnson
Location: Spring House
Posted on: June 25, 2022
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Job Description:
Janssen Research & Development, L.L.C., a member of Johnson &
Johnson's Family of Companies, is recruiting for a Principal
Medical Writing Specialist in the Titusville, New Jersey area,
U.K., Europe, Belgium, Switzerland, or Canada. Remote work options
may be considered, on a case-by-case basis and if approved by the
Company! Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical
needs in oncology, hematology, immunology, neuroscience, infectious
diseases, cardiovascular, metabolic, mental health, and pain
management, and vaccines, and cardiovascular and metabolic
diseases. Please visit http://www.JanssenRnD.com for more
information. Janssen thrives on a diverse company culture,
celebrating the uniqueness of our employees and is committed to
inclusion. Janssen is proud to be an equal opportunity employer.
Our culture is interconnected by the shared values of Our Credo. It
is a culture that celebrates diversity and diverse perspectives,
and helps its employees achieve an effective balance between work
and home life and supports their efforts to have a positive impact
on their communities. Position Summary: Able to write and
coordinate basic and complex documents, independently when working
within own TA, and under supervision when working across TAs. Leads
in a team environment and matrix. Able to function as a lead MW on
most compounds, under supervision. May actively participate in or
lead process working groups. Provides input into functional
tactics/strategy (eg, writing teams, process working groups).
Highly proficient in the use of internal systems, tools, and
processes.Principal Responsibilities: Writes or coordinates
clinical and regulatory documents such as, but not limited to,
CSRs, IBs, protocols, summary documents, RMPs, regulatory
responses, and briefing documents. Leads cross-functional (eg, with
clinical team) document planning and review meetings. Interacts
with cross-functional colleagues on document content and champions
MW processes and best practices. Responsible for establishing
document timelines and strategies in accordance with internal
processes, with some mentorship from functional management and
clinical team, as needed. Completes all time reporting, training,
metrics database, and project tracking updates as required in
relevant company systems. Able to function as a lead writer on most
compounds (or submissions, indications, or disease areas) under
supervision. Is primary point of contact for medical writing
activities for the cross-functional team (eg, clinical). Coaches or
mentors more junior staff on document planning, processes, and
content. Provides peer review as needed. May actively participate
in or lead process working groups.Principal Relationships:
Internal: manager, other writers cross-functional contacts (eg,
clinical, regulatory, or biostatistical functions) involved in the
preparation and planning of clinical documents. External: May
interact with or oversee day-to-day work by contractors or external
service providers as needed under supervision. May collaborate with
external partner company staff on codeveloped compounds.
QualificationsEducation and Experience Requirements: A
university/college degree is required. An advanced degree (eg
Masters, PhD, MD) is preferred. At least 6 years of relevant
pharmaceutical/scientific experience is required. At least 4 years
of relevant clinical/regulatory medical writing experience is
required.Other: Recognizes how to best interpret, summarize, and
present statistical and medical information to ensure quality and
accuracy of content in complex document types under general
supervision. Excellent oral and written communication skills.
Attention to detail. Ability to function in a team environment.
Organizes time well. Strong leadership skills, both in project and
process management as well as in time management(influencing,
negotiating, assertiveness, taking initiative). Resolves complex
problems under supervision. Demonstrates learning agility. Builds
solid and productive relationships with cross-functional team
members. At Johnson & Johnson, we're on a mission to change the
trajectory of health for humanity. That starts by creating the
world's healthiest workforce. Through cutting-edge programs and
policies, we empower the physical, mental, emotional and financial
health of our employees and the ones they love. As such, candidates
offered employment must show proof of COVID-19 vaccination or
secure an approved accommodation prior to the commencement of
employment to support the well-being of our employees, their
families and the communities in which we live and work. Johnson &
Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, age, national origin, or protected veteran status
and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our
employees throughout their wellness, career and life journey,
please visit www.careers.jnj.com . Primary LocationUnited
States-Pennsylvania-Spring House-Welsh & McKean RoadsOther
LocationsNorth America-Canada, Europe/Middle
East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom,
Europe/Middle East/AfricaOrganizationJanssen Research &
Development, LLC (6084)Job FunctionRRequisition ID2206004706W
Keywords: Johnson & Johnson, Philadelphia , Principal Medical Writer, Advertising , Spring House, Pennsylvania
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