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Associate Director, Medical Writing - Oncology

Janssen Research & Development, LLC, a member of the J&J
Family of Companies, is recruiting for an Associate Director, Medical Writing ?
Oncology, to be located in either Titusville, NJ; Raritan, NJ; Spring House,
PA, or High Wycombe, UK. This position may require up to 10%
travel.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We focus on
treating, curing and preventing some of the most devastating and complex
diseases of our time. And we pursue the most promising science, wherever it
might be found.
Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical needs in
oncology, immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more
information.
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
Responsibilities:
+ Prepare and finalize all types of clinical and
regulatory documents with in the Oncology therapeutic area, taking a
proactive lead role in terms of content and scientific strategy. Documents
must be of high quality in terms of scientific content, as well as
organization per regulatory and internal guidance, clarity, and accuracy,
with attention to format and consistency.
+ Lead in a team environment, and work with a high-level
of independence, while leading assigned projects with respect to timing,
scheduling, and tracking.
+ Directly lead and set objectives for others on team
projects and tasks.
+ Guide and train cross-functional team members on
processes, best practices; coach and mentor more junior writers.
+ Lead writing teams with independence.
+ Proactively identify and champion departmental process
improvements.
+ Develop and present best practices to external
audiences.
+ Lead cross-functional/cross-Therapeutic Areas,
cross-J&J process improvement initiatives.
+ Able to function as a Lead Writer, with principal
responsibilities to include, but be not limited to:
+ Primary
point of contact for Clinical/Global Program Team for medical writing
activities.
+ Responsible
for functional planning and metrics database updates for assigned program.
+ Responsible
for championing medical writing best practices on assigned program.
+ Responsible
for setting strategy and leading writing group on health authority submissions.
+ Eventually
able to function as a people manager, with principal responsibilities to
include, but not be limited to:
+ Supervise/manage
others on the team and set objectives for individual team members.
+ Regularly meet
with direct reports to ensure appropriate development, projects, assignments,
and issues are resolved.
+ Make decisions on
hiring staff, onboarding new staff, conducting career and talent development
discussions for staff, leads in goal-setting and end of year calibration
reviews and performance discussions, and contribute to compensation planning.
Qualifications
Qualifications:
+ A
Bachelors
Degree with at least 10 years of relevant pharmaceutical/scientific
experience, OR a Masters Degree with at least 8 years of relevant
pharmaceutical/scientific experience is required.
+ An advanced degree, such as MS or PhD, is preferred
+ At least 8 years of relevant medical writing experience
is required.
+ Extensive
experience writing clinical regulatory documents such as, but not limited
to clinical trial protocols, clinical study reports, Summaries of Clinical
Efficacy and Safety/Clinical Overviews, health authority briefing
documents and response documents is required.
+ Demonstrated
ability to interpret and organize scientific data (e.g. written clinical
and/or regulatory documents for drug development, published manuscripts,
etc.) is required
+ Experience
with MS Office Suite (Excel, Word, PowerPoint) is required
+ Experience
using AMA, ICH, or similar guidelines is preferred
+ Experience
with medical writing document standards and processes is preferred
+ Experience
using document repository software (e.g. Documentum) is preferred
+ Research experience (including compilation of research
reports or publications) in academia or the pharmaceutical industry or as
part of a PHD, Pharm.D or postdoctoral program is preferred
+ Experience in project management and
process improvement is required.
+ Excellent oral and written communication skills are required.
+ Ability to lead in a team environment is required.
+ Advanced
knowledge and application of regulatory guidance documents such as ICH
requirements is preferred.
+ Fluency (both oral and
written) in English (completely comfortable
communicating on a detailed, professional level) is required.
Primary Location
United States-New Jersey-Titusville-
Other Locations
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Medical Writing
Requisition ID
00001DVW


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