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:
Medical Affairs Group
Job Sub Function:
Medical Affairs
Job Category:
Scientific/Technology
All Job Posting Locations:
Toronto, Ontario, Canada
Job Description:
Johnson \& Johnson is recruiting for a Scientific Review Manager to be located in Toronto, Ontario, Canada, for a duration of 19 months.
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.
The Scientific Review Manager is responsible for providing expert advice relevant to the development of medical materials produced by the Medical Affairs department or agency partners for the purpose of scientific exchange or medical education. The Scientific Review Manager also leads a range of medical material initiatives and projects.
The Scientific Review Manager establishes and maintains trusted relationships with Medical Affairs peers including the Medical Affairs Operations Manager, National Medical Education Managers (NMEMs), Medical Information/Communications Managers, Scientific Advisors (SAs), and Medical Science Liaisons (MSLs) to collaborate in gathering business requirements, support the development of new or revised materials of varying complexity, and understand business/customer impact.
Key Responsibilities:
- Provide expert advice on compliance and risk management strategies pertaining to medical materials.
- Lead the review and approval of balanced, compliant, and credible medical materials for external use and dissemination to HCPs.
- With a strong proficiency in scientific material content, review and classify medical materials by identifying the level of risk, and collaborate with compliance stakeholders such as Regulatory, Legal, and Health Care Compliance as required.
- Lead discussions on the execution of business initiatives related to medical materials, proposing innovative solutions for the compliant and efficient integration of new capabilities in Medical Affairs.
- Provide leadership to the Medical Materials Review team and the larger Material Review team through collaboration on processes and key compliance objectives.
- Work with internal Medical Affairs business partners and external vendors to ensure that all submitted medical materials meet high standards of quality, adhere to corporate and industry regulations, and meet business objectives.
- Ensure that all materials are reviewed and produced as per the Standard Operating Procedure (SOP) and adhere to Health Canada and IMC guidelines. Raise issues appropriately and ensure that deviations are documented and resolved.
- Maintain all documentation as outlined in the SOP to establish an accurate audit trail.
- Lead Material Review team projects and initiatives and participate in special projects as agreed upon.
Requirements:
- A minimum of a Master's degree is required; a PhD, PharmD, or MD is preferred.
- Proficiency and experience in the creation and review of scientific materials, and academic reference standards is required.
- A minimum of 5-8 years of experience in related areas in the pharmaceutical industry (Medical Affairs, Quality/Compliance, Clinical Operations, Medical Writing, and/or Medical Information/Communications) and a track record of collaboration in a matrixed environment is required.
- In-depth level of industry knowledge (IMC and Health Canada) is required.
- Strong aptitude for the interpretation and application of regulations and standard operating procedures.
- Proven track record to effectively apply the regulations, handle multiple priorities, and negotiate for acceptance.
- Demonstrated ability to effectively negotiate with and influence internal and external partners to ensure compliance while meeting business needs.
- Strong attention to detail, accuracy, and process adherence.
- Ability to apply independent judgment in handling and resolving problems/issues.
- Excellent planning and organizational skills with a strong ability to multi-task and prioritize workload.
- Strong customer focus with excellent interpersonal, influencing, and written/verbal communication skills.
- Ability to promote team cooperation and a commitment to team success.
- Ability to build and sustain trusted relationships both internally and externally.
- Proficiency with Microsoft Office software and familiarity with other digital media formats.
