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

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https: //www.jnj.com/innovative-medicine

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Lead, Trial Delivery Manager to be in São Paulo, Brazil.

Purpose: The Medical Affairs – Delivery Unit, Lead, Trial Delivery Manager (TDM), Managed Access is responsible for the execution of program-level activities, creating and updating program-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery.

The TDM might have responsibilities cross different trial types (such as Company Sponsored, Investigator Initiated, and Collaborative Studies), within different Therapeutic Areas, in a local, regional, or global setting, depending on the business need.

You will be responsible for:

• Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).

• Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.

• Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).

• Support development of program-level compound training, collaborating with Clinical / CTL& D / Medical writing.

• Provide input into trial level operational strategies.

• Resolve trial-related issues and mitigate trial-related risks.

• Participate in process improvement activities at a trial, compound & cross-DU level, as needed.

• Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.

• Mentor & support onboarding of new team members, particularly those in Trial Management

Qualifications / Requirements:

• BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

• Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.

• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.

• 2-3 years’ experience supporting global clinical trials.

• Native Portugese and advance English level is required.

• Experience with local regulatory expertise( Brazil Health Authorities and compliance laws).

• Excellent leadership skills and proven ability to foster team productivity and cohesiveness.

• Experience leading without authority and in muti-functional matrixed and global environments.

• Excellent decision-making, analytical and strong financial management skills are essential to this position.

• Operate and execute with limited supervision. Experience mentoring/coaching others.

• Ability to support and participate in the hiring, training, development, and evaluation of staff on a regular basis.

• Strong project planning/management, communication and presentation skills are required.

Other:

• Travel up to 15-20% of the time, defined by business needs.

• Preferred Related Industry Experience:

• Pharmaceutical, Biopharmaceutical, Biotechnology