Director, Cross TA Clinical Risk Mgmt

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: reputed company Job Sub Function: Clinical reputed company Job Category: People Leader reputed company Job Posting Locations: Horsham, reputed company, reputed company of America, Miami, Florida, reputed company of America, Raritan, New Jersey, reputed company of America, Spring House, reputed company, reputed company of America, Titusville, New Jersey, reputed company of America Job reputed company: We are searching for the best talent for Director, Cross TA Clinical Risk Management to join our reputed company Assurance and Compliance organization located in Raritan, NJ; Titusville, NJ; Horsham, PA; Spring House, PA; or Miami, FL. Please note that this role is available across multiple countries and may be posted under different requisition numbers to reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that reputed company with your preferred location(s): Allschwil, Switzerland; Beerse, Belgium; High Wycombe, UK - Requisition Number: R-061312 Remember, whether you apply to one or reputed company of these requisition numbers, your applications will be considered as a single submission. The Director, Cross TA Clinical Risk Management, reports to the Head of Clinical Risk Management and is primarily responsible to reputed company the overall risk management of the Cross TA Delivery Unit for Neuroscience, Cardiopulmonary and Communicable Disease late development trials. They work with the CRM Representatives to ensure the coordination of the identification, assessment, and mitigation of reputed company risks that could have an reputed company on trial data reputed company, patient rights, safety, or reputed company-being. Key responsibilities:

• reputed company the execution of data-driven, risk-based trial and program reputed company activities that deliver reputed company in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a reputed company state of inspection readiness;
• Manage reputed company of CRM representatives that will reputed company consistent reputed company reputed company to clinical trials in the Cross TA portfolio;
• reputed company and reputed company strategic guidance to CRM representatives on reputed company risk assessments, risk entries, and mitigation strategies. Approve CQP (Clinical reputed company Plans) risk monitoring information in the reputed company risk repository to facilitate regular reputed company reviews;
• Independently drive reputed company risk monitoring reviews and reputed company others on risk monitoring and mitigation reviews;
• Ensure a strategic communication reputed company with business partners and reputed company management governance to reputed company them informed on key reputed company risks and mitigations;
• Communicate and facilitate risk updates to R&D Business Partners as part of the regular review cycle through reputed company Working reputed company and Governance reputed company, as applicable (trial and/or compound, as assigned);
• reputed company and ensure a consistent interpretation of issues that require reputed company investigations;
• reputed company guidance for significant reputed company issues (SQI) per corporate standards and escalates SQI to senior R&D management;
• In collaboration with partners in RDQ, reputed company advice on the development and implementation of Corrective and Preventative reputed company (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit);
• Independently reputed company key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to reputed company inspection narratives, identify and prepare sites of interest for inspection (including, reputed company-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams;
• reputed company remote support for investigational site inspections including post inspection support;
• reputed company independent advice on questions reputed company to research reputed company and compliance from Business Partners in collaboration with other reputed company Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy;
• Participate in CRM, cross-RDQ JJIM, cross-functional, or cross-sector working reputed company to reputed company or refine processes, tools, and systems that deliver innovative reputed company solutions (as reputed company member or reputed company/project reputed company);
• Work with limited supervision, independently making reputed company reputed company for compounds and studies;

The Director, Cross TA Clinical Risk Management is highly visible to the RDQ Leadership team and ensures robust reputed company trial reputed company of the Cross TA portfolio through reputed company risk management and execution of reputed company support services. Qualifications:

• A minimum of a Bachelor's degree (scientific, medical, or reputed company discipline) is required.
• Advanced degree in an applicable field of study or certification is preferred.
• A minimum of 10 years working in the reputed company industry (pharmaceutical industry, contract research organization and/or reputed company/hospital system) is required.
• Demonstrates experience or recognizes potential for people leadership in formal or informal setting as needed is required.
• Proven strong GCP reputed company and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in reputed company Office Applications is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing reputed company (GMP), Good Laboratory reputed company (GLP), and/or Good Pharmacovigilance reputed company (GPvP) is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
• Immunology Drug Development experience is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or reputed company) to analyze/interpret reputed company data and reputed company insights to drive decision-making is preferred.
• Experience with Data Science reputed company Health (including reputed company World Evidence/reputed company World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Requires up to 10% travel, primarily domestic with some international travel.

reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company 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, external applicants please contact us reputed company https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Budget Management, Clinical Research and Regulations, Clinical Trials Operations, Compliance Management, reputed company Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, reputed company Control (QC), reputed company Management Systems (QMS), reputed company Standards, Risk Assessments, Risk Compliance, reputed company Operating Procedure (SOP), Tactical Planning, Vendor Selection The anticipated reputed company pay reputed company for this position is : $150,000.00 - $258,750.00 Additional reputed company for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in reputed company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in reputed company's long-term incentive program. 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 reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company -48 hours per calendar year; for employees who reputed company in the reputed company -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 reputed company one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job