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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:

Data Analytics & Computational Sciences

Job Sub** **Function:

Clinical Data Management

Job Category:

People Leader

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US)

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for an **Associate Director, Medical Writing & Literature Services** . _Remote work options may be considered on a case-by-case basis and if approved by the Company_ .

**Purpose** : The Associate Director, Medical Writing and Literature Services acts as the central process owner for the general medical writing activities and systematic literature reviews across J&J MedTech Surgery in support of Clinical, Medical, and Regulatory needs. These medical writing activities and systematic literature reviews support the generation of clinical evaluation reports (CER), summaries of safety and clinical performance (SSCP), post-market surveillance reports (PSMR), periodic safety update reports (PSUR), new product development (NPD) evidence generation strategies, premarket approval (PMA) annual reports, and Health Authority requests for all therapeutic areas / operating companies / platforms within the J&J MedTech Surgery business unit.

**You will be responsible for** :

+ Directs the planning and execution of systematic literature reviews (inclusive of protocol, search, screen, data extraction, analysis, and full summary report) for all applicable deliverables and processes, ensuring timely delivery of high-quality literature services and documentation as well as consistent deployment across MedTech Surgery.

+ Develops, implements, and maintains relevant procedures and templates, best practice and style standards, reference libraries, reviewer guidelines, and quality control tools/measures.

+ Manages the utilization of software to support systematic literature reviews, including statistical analysis tools.

+ Ensures the medical writing processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.), supporting data/information accessibility.

+ Manages Medical Writing staff (i.e., medical writers and reviewers, project management staff, librarians, medical information specialists, programmers, as applicable to organizational structure).

+ Provides strategic oversight and guidance for Medical Writing staff and cross-functional business partners, if applicable, to all resources on compliant literature service execution and document generation.

+ Establishes and maintains resource allocation / forecasting and operational direction for direct reports to achieve high-quality deliverables in an efficient manner.

+ Maintains responsibility for talent acquisition and comprehensive training.

+ Supports the professional development of direct reports.

+ Leads literature process optimization with focus on improving efficiency, automating, and standardizing literature searching and reporting, staying current with industry trends and regulations.

+ Partners with Global Clinical Evaluation teams and cross-functional business partners such as Medical Affairs, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes.

+ Acts as the Global Clinical Evaluation literature services SME / liaison with respective Notified Bodies and regulatory agencies during audits and inspections.

+ Tracks key performance indicators, maintains/monitors metrics, and reports issues or opportunities for improvement to Global Clinical Evaluation leadership.

+ Supports the J&J MedTech literature subscription process, enabling and maintaining appropriate access to the journals for cross-functional teams.

+ Assists in the development and management of the Global Clinical Evaluation budget including performing budget updates, ensuring appropriate assignment of resources, and approving invoices.

+ Identifies and collaborates with vendors/service providers to source contract services necessary to accomplish literature services goals and objectives.

Qualifications / Requirements:

+ Minimum of a Bachelor’s Degree **required** ; Advanced Degree _strongly preferred_ .

+ Minimum 7 years of related medical writing experience including systematic literature reviews with minimum 3 years of people leadership experience **required** .

+ Experience mentoring medical writers, managing high-volume project work, and supervising internal and external writers/vendors **required** .

+ Experience within the medical device industry and with clinical evaluation report regulatory requirements **required** ; thorough understanding of global medical device regulations and guidelines (e.g., FDA, EU MDR) **required** .

+ Demonstrated knowledge and experience in narrative or systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative and quantitative synthesis in conjunction with scientific and medical writing **required** .

+ Demonstrated knowledge and experience in clinical research methodologies with common biostatistical methods, systematic reviews and clinical data appraisal, and medical writing **required** .

+ Change management expertise **required** .

+ Certification or 2+ years of project management experience _preferred_ .

+ Experience developing and implementing literature search / reporting systems, processes, and tools required; knowledge of automation / artificial intelligence opportunities _preferred_ .

+ Experience in complaint handling, adverse event reporting, and risk management processes _preferred_ .

+ Knowledge of evidence generation strategies _preferred_ .

+ Regulatory/Notified Body front room audit experience _preferred_ .

+ Budgetary and financial planning experience _preferred_ .

+ Position can be performed remotely.

+ 20% Domestic and International Travel required.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

\#LI-Remote

Required Skills:

Clinical Research Methods, Medical Device Regulations, Medical Writing, People Leadership, Scientific Literature Reviews

Preferred Skills:

Change Management, Clinical Evaluation Reports, Evidence Generation, Vendor Management

The anticipated base pay range for this position is :

The base pay range for this position is $137,000 to $235,750.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits