Manager, Medical Writing (DePuy Synthes) - Medical Device Business Services, Inc. - 2406180317WDescriptionMedical Device Business Services, part of the Johnson & Johnson family of companies, is currently recruiting for a Manager, Medical Writing to support our DePuy Synthes business. The preferred locations for this role are within a commutable distance of Warsaw, IN or Raritan, NJ however remote options will be considered on a case-by-case basis.About Johnson & JohnsonAt 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/.The Medical Writing Manager provides leadership, motivation, process oversight, people and project management, and strategic direction across medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), PMA FDA Reports, and State of the Art (SOA) Reviews for assigned therapeutic areas within Johnson & Johnson Global Medical Device (HMD) businesses within their scope of responsibility.Primary Responsibilities :
Manages and oversees the generation of protocols and reports according to company procedures.
Develops and monitors business relevant metrics for medical writing activities for their assigned businesses.
Communicates business related issues and opportunities to the next management level and enables corrective and preventive action to be taken as necessary.
Manages relationships with external vendors for the generation of documents supporting medical writing activities.
Supervises and manages staff, ensures that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all applicable resources needed to do so are available and in good condition.
Ensures personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
In conjunction with the Medical Writing Director, designs and develops global processes and related documents; develops and leads related workshops.
Keeps abreast of regulatory requirements and industry trends/practices and ensures that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies.
Oversees project plans across medical writing activities and gathers information (timelines, projects, documents) to forecast and budget resources needs for deliverables.
Participates in discussions and actively liaises with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs to provide scientific and medical strategic planning and execution for assigned medical writing activities.
Demonstrates proficiency in assigned therapeutic areas, provides expertise in device technology.
Oversees and confirms the interpretation of clinical data by team members, including but not limited to research methodology and study design.
Ensures team compliance with medical device regulations globally and escalates any new or emerging risks.
Provides input on clinical data from the medical and scientific literature to ensure results are presented in a clear, concise, and scientifically accurate manner requiring the ability to understand and interpret statistical results of clinical studies.
Manages and provides strategies that feed into core process steps for the planning of reports including literature search, article screening, data extraction from publications, and synthesis.
Ensures alignment of data synthesis outputs (e.g. reports) with related documents.
Drives utilization of software to support the core process steps ncluding project management and statistical analysis tools (e.g. Distiller, QUOSA, SAS, RightFind, Wrike) and provides operational direction to the end users of these tools for assigned projects.
Formulates/provides responses to queries from regulatory bodies (e.g. Notified Bodies).
Trains new staff (Other Managers, Senior Medical Writers, Writers, and Medical Information Specialists) on department processes and procedures.
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, [long-term incentive – include LTI only if applicable] 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-benefitsQualificationsRequired Qualifications :
Minimum of a Bachelor’s Degree is required ; Advanced Degree strongly preferred .
At least 8 years of related Medical Writing experience within the Medical field; 5 years with Masters Degree, 3 years with a PhD .
Knowledge of medical device regulatory requirements or Clinical Evaluation Report (CER) document creation is required .
Demonstrated knowledge Clinical research, Quality regulatory compliance, and Adverse event reporting is strongly preferred .
Experience in managing teams and/or coaching/mentoring junior staff is required .
Skilled in narrative or systematic literature reviews (PRISMA, Cochrane) with demonstration in qualitative and quantitative data analysis in conjunction with scientific and medical writing is strongly preferred .
Ability to understand and interpret statistical results of clinical studies and understand good data management practices is required.
Experience in and evidence of (e.g. publications) excellent scientific/medical writing ability is required.
Experience using software systems to manage literature data (i.e Distiller) is highly desired .
Ability to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence is required.
Proficiency in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager) is strongly preferred .
Strong oral communication, presentation, project management and prioritization skills and excellent interpersonal relationships is required.
Up to 10% travel domestic & international may be required based on business needs.
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 .This job posting is anticipated to close on 4/23/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Primary Location NA-US-Indiana-WarsawOther Locations NA-United States, NA-US-New Jersey-RaritanOrganization Medical Device Business Services, Inc (6029)Job Function Clinical/Medical OperationsReq ID: 2406180317W
