Manager, Scientific Operations - Medical Device Business Services, Inc.
Company: Disability Solutions
Location: Raritan
Posted on: April 20, 2024
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Job Description:
Johnson & Johnson MedTech, a member of Johnson & Johnson family
of companies, is recruiting for a Manager, Scientific Operations
Technical & Medical Writing . The preferred location for this
position is Raritan, NJ or Irvine, CA however remote options within
the United States will be considered on a case-by-case basis. About
Johnson & Johnson 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 The Scientific Operations (SciOps)
Technical & Medical Writing Manager, will provide strategic
oversight and governance ensuring compliance in Sci Ops functions
charged with delivery of key regulatory and medical documents. You
will lead a diverse Sci Ops team based globally and will ensure the
identification and retention of high potential individuals through
active engagement, motivation, employee development, and promotion.
Specifically, the Manager will lead the execution of Clinical
Evaluations and Summaries of Safety and Clinical Performance (SSCP)
for multiple MedTech franchises. Additionally, the manager would
support the review of Literature Reviews and Periodic Safety
Updates in compliance with the EU MDR. The manager will provide
leadership and maintain relationships through extensive
interdependent partnering, benchmarking, and forming strategic
alliances with cross functional business partners to drive key
business goals and objectives. Furthermore, the manager will lead
interactions with the Notified Body and the drafting and alignment
on response strategy and execution. Primary Responsibilities : ---
Lead a team of medically proficient scientists and technical
writers across the various J&J Med Tech franchises to compile
and analyze product related safety and performance data,
collaborate on strategy, draft reports and coordinate approvals.
--- Be responsible for the effective optimization and harmonization
of CER and SSCP processes within MedTech while aligning with
available guidelines. --- Ensure the CER and SSCP processes are
linked to appropriate Quality Systems and Regulatory Processes to
ensure information is accessible where needed and will develop,
implement and be responsible for an effective communication model.
--- Generate materials, lead workshops, and deliver training to
ensure adequate implementation of guidelines and contribute to the
professional development of employees. --- Develop and supervise
performance and compliance metrics providing visibility of issues
and enabling risk mitigation, corrective and preventive action to
be taken as needed. --- Partner with R&D, Medical Affairs,
Clinical, and Regulatory in the establishment of appropriate routes
of conformity for clinical evaluations for new products
introductions and product design changes. --- Track and trend
Notified Body questions and observations across applicable MedTech
franchises to improve processes and enhance compliance. Translate
insights into viable process and solutions that create value. ---
The base pay range for this position is $115,000 to $175,000 based
on experience . The Company maintains highly competitive,
performance-based compensation programs. Under current guidelines,
this position is eligible for an annual performance bonus. 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 may be eligible to
participate in Company employee benefit programs such as health
insurance, savings plan, pension plan, disability plan, vacation
pay, sick time, holiday pay, and work, personal and family time off
in accordance with the terms of the applicable plans. Additional
information can be found through the link below.
Keywords: Disability Solutions, Edison , Manager, Scientific Operations - Medical Device Business Services, Inc., IT / Software / Systems , Raritan, New Jersey
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