Senior Technical Writer
Company: J&J Family of Companies
Location: Boise
Posted on: January 26, 2023
Job Description:
Senior Technical Writer - 2206097263WDescriptionDePuy Synthes is
recruiting for a Senior Technical Writer, Medical Operations,
located in Warsaw, IN! Remote work options may be considered on a
case by case basis if approved by the company.DePuy Synthes, part
of the Johnson & Johnson Medical Devices Companies, provides one of
the most comprehensive orthopedics portfolios in the world. DePuy
Synthes solutions, in specialties including joint reconstruction,
trauma, craniomaxillofacial, spinal surgery and sports medicine,
are designed to advance patient care while delivering clinical and
economic value to health care systems worldwide. For more
information, visit www.depuysynthes.com.Key Responsibilities:
- Responsible for the technical review ensuring the accuracy and
compliance of Clinical Evaluation Plans (CEP), Clinical Evaluation
Reports (CER) and Summary of Safety and Clinical Performance (SSCP)
documents
- Responsible for compliant writing of Clinical Evaluation
Reports and Plans within this business in accordance to local
procedures, J&J guidelines and regulatory requirements
- Responsible for ensuring compliant creation of SSCP documents
within this business in accordance to local procedures, J&J
guidelines and regulatory requirements
- Ensures the CER and SSCP files are linked to appropriate
Quality Systems and Regulatory documents (e.g., Risk Management,
PMS, etc.) to make certain information is consistent and accessible
where needed. They will develop, implement, and manage an effective
communication model for CERs/SSCPs with cross functional business
partners
- Assists in the development of schedules to ensure operating
company CER/SSCP timelines are met
- Participates in workshops and on initiatives to help define
processes globally and keep abreast of CER regulatory requirements
and industry trends/practices, ensuring that a proactive ongoing
review of processes and procedures is in place to maintain a strong
regulatory profile while continually improving process
efficiencies
- Supports and at times acts as an SME during audits and
inspections pertaining to CER/SSR processes and
reportsQualificationsEducation:
- BA, BS, or BSN is required; advanced degree is
preferredExperience and Skills:Required:
- A minimum of 5 years of related job experience is required for
this position
- Experience within the medical device industry and knowledge of
clinical evaluation report regulatory requirements, evidence
generation, and CER document creation is required
- Fluent both oral and written in EnglishPreferred:
- Demonstrated knowledge and experience in quality regulatory
compliance, complaint handling, adverse event reporting, medical
device risk management processes, and experience with common bio
statistical methods is preferred
- Regulatory/Notified Body audit experience is preferredOther:
- Actively partners with cross-functional business partners such
as Other Medical Operations Team Members, Medical Affairs,
Regulatory Affairs, Product Development, Clinical Research, Post
Market Surveillance, Quality Engineering, and Patient Harm Coding,
in the planning and execution of the clinical evaluation
process
- Works with vendors/service providers to source contract
services necessary to accomplish their goals and objectives
- 10% Domestic and International Travel requiredThe 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 corporations
performance over a calendar/performance year. Bonuses are awarded
at the Companys discretion on an individual basis.The base pay
range for this position is $102,000 to $142,000The base pay range
for this position in the Bay Area of California is $116,700 to
$163,300Employees 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.https://www.careers.jnj.com/employee-benefitsAt Johnson &
Johnson, were on a mission to change the trajectory of health for
humanity. That starts by creating the worlds 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 Location NA-US-Indiana-WarsawOther
Locations NA-United StatesOrganization Medical Device Business
Services, Inc (6029)Relocation Eligible: NoTravel Yes, 10 % of the
TimeJob Function Medical AffairsReq ID: 2206097263W
Keywords: J&J Family of Companies, Boise , Senior Technical Writer, Advertising , Boise, Idaho
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