FUNCTIONAL MANAGER BUSINESS OPERATIONS I

The Functional Manager Business Operations I (FMBO I) is accountable for strategic and operational management of clinical trials EC&HA submission through the management of a dedicated submission team.
You will be responsible for overseeing resources at departmental level, providing managers and directors with the information they need to make decisions.
You will be accountable for the monitoring of metrics, study budget and local vendors oversight at department level, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements.
In this position you will support the Local R&D Head and the TA director in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.
Your responsibility will be line management of analysts, assistants and local managers belonging to the Submission Team and/or other GCO staff, as required.
Supports employees with performance, development, training, project assignments, workload distribution and issue resolution.
Ensures alignment of local goals with organizational objectives.
Drives innovative solutions and process improvements for the assigned therapeutic area(s), country and GCO/ Global Development (GD)overall.
Principal Responsibilities.
1.
Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
2.
Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
3.
Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
4.
Interview, hire, develop and train staff.
5.
Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance, as required.
6.
Support direct reports in issue resolution and communication with involved stakeholders 7.
Support local implementation of organizational changes and effectively communicate on priority shifts.
8.
Review and approve expenses in compliance with the company policies.
9.
Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives 10.
Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
11.
Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
12.
Define, execute or support of long term strategy in alignment with GCO, GD and Janssen R&D strategies to position the local and global GCO organization for success.
13.
Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
14.
Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
15.
Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
Contribute to CAPA and issue resolution in accordance with required timelines.
16.
Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
17.
Develop country capabilities for an effective EUCTR submissions of trials conducted at department level, keep a regulatory watch, develop a strong networking with internal and externals stakeholders to improve EUCTR process 18.
Develop country capabilities for an effective metric review and drive necessary follow-up actions.
19.
Develop country capabilities for an effective budget management at trial and local vendors level.
20.
Accountable for appropriate oversight of local vendors from qualification to oversight.
21.
Contribute to development, evaluation and implementation of new processes and systems to improve study management.
22.
Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
23.
Foster a culture of continuous improvement and innovation within the local GCO team.
24.
Model Credo based culture within the local GCO team.
Qualifications Education and Experience Requirements.
Bachelor's degree or equivalent required, preferably in Life Sciences (e.
., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
Effective communication and leadership skills.
Ability to foster team productivity and cohesiveness.
Experience in mentoring/coaching others (line management experience desirable).
Skilled in leading, hiring, training, developing and evaluating people.
Solid decision-making, resources and financial management skills.
Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.
Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
Ability to synthesize and evaluate data generated from various reports and sources.
Demonstrated skills in effective communication with various internal and external stakeholders (e.
.
investigational sites, ethics committees, health authorities, etc.).
Flexible mindset and ability to work in a fast-changing environment.
Operates under limited supervision.
Proficient in English language.
Computer literacy.
Strong interpersonal and negotiating skills.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
Perform activities in a timely and accurate manner.
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 https://www.
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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.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.