Senior Manager/Associate Director, Regulatory Medical Writing X-TA

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This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function: Medical Affairs Group
Job Sub
Function: Medical Writing
Job Category: People Leader
All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description: Senior Manager/Associate Director, Regulatory Medical Writing X-TA
At Johnson & Johnson Innovative Medicine, 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. Our
expertise
in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
https://www.jnj.com/innovative-medicine We are searching for the best talent for a
Senior Manager
/Associate Director
,
Regulatory Medical Writing
within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA
(Cross Therapeutic Area)
Regulatory Medical Writing area. The position can be
located
at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),
Allschwil
(Switzerland) or Spring
House/Raritan/Titusville
(East Coast US). Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case
basis and
if approved by the company. Are you ready to join our team? Then please read further!
You will
be responsible for
:
Leading compound/submission/
indication
/disease area writing teams independently.
May have
additional
major responsibility with supervision.
Cross-functional, cross-TA, or cross-J&J
initiative/collaboration.
Larger organizational responsibility (
eg
, manage a subset of TA).
Preparing and
finalizing
all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with
a high level
of independence and taking a lead role on with respect to timing, scheduling, and tracking.
Leading
program-level/submission
writing teams independently.
Directly leading or setting
objectives
for others on team projects and tasks.
Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
Proactively
identifying
, contributing
to
and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
Leading
cross‐functional/cross‐TA,
cross‐J&J process improvement initiatives, or other large process working groups.
Developing,
maintaining
and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
If a lead writer for a program:
Primary point of contact and champion for Medical Writing activities for the clinical team.
Responsible for planning and leading the writing group for assigned program.
Able to function as a lead writer on any compound independently.
Leading discussions in Medical Writing and cross‐functional meetings as
appropriate
.
Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
Able to oversee the work of external contractors.
As a people manager:
Manage direct reports in Medical Writing.
Set
objectives
for individual team members.
Regularly meets
with direct reports to ensure
appropriate development
, projects, assignments, and issues are resolved.
Ensures direct report's adherence to
established
policies, procedural documents, and templates
Able to make decision on hiring staff, onboarding
new staff
, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
Qualifications /Requirements:
University/college degree in a scientific discipline is
required
.
Masters
or PhD preferred.
At least 10 years of relevant
pharmaceutical/scientific
experience; at least 8 years of relevant Medical Writing experience is
required
!
A
t least 2 years of people management experience.
Multiple therapeutic area experience preferred.
Strong attention to detail.
Strong oral and written communication skills. Fluent written and spoken English.
Expert project management skills, expert project/process improvement leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
Ability to delegate responsibility to junior writers.
Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to
comply with
local requirements. While you are welcome to apply to any or
all of
the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom - Requisition Number: R-
027208 Belgium, Netherlands - Requisition Number: R-
028681 Switzerland - Requisition Number: R-028682 United States - Requisition Number: R-028683
Rememb
er, whether you apply to one or
all of
these requisition numbers, your applications will be considered as a single submission. For United States applicants:
The
anticipated
base pay range for this position is $137,000 to $235,750 (USD)
. The Company
maintains
highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus
in accordance with
the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by
rewarding for
individual and the corporation's performance over a calendar/ performance year.
Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to
participate
in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to
participate
in the Company's
consolidated
retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: - Vacation - up to
120 hours
per calendar year Sick time - up to
40 hours
per calendar year; for employees who
reside
in the State of Washington - up to
56 hours
per calendar year
- Holiday pay, including Floating Holidays - up to
13 days
per calendar year - Work, Personal and Family Time - up to
40 hours
per calendar year For
additional
general information on company benefits, please go to:
https://www.careers.jnj.com/employee-benefits The compensation and benefits information
set forth in
this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits
in accordance with
their local market. 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. #LI-Hybrid #LI-Remote
The anticipated base pay range for this position is : $137,000 to $235,750 (USD) Additional Description for Pay Transparency:
Apply
Location:
Hopewell Township
Job Type:
FullTime

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