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Sr. Manager, Global Clinical Science

Company: MicroVention-Terumo
Location: Aliso Viejo
Posted on: June 19, 2022

Job Description:

Drive clinical and scientific activities associated with the design, conduct and reporting of clinical trials for assigned therapeutic areas, interfacing with the Regulatory, Clinical Research, R&D, and Marketing departments; and have significant interaction with executive leadership, physicians and regulatory authorities. Oversee planning and execution of clinical evaluations to support design validation and risk management activities, act as a subject matter expert and provide scientific input for development of regulatory and/or marketing strategies, and support for communications with global regulatory authorities during the complete lifecycle of MicroVention products. Job duties:What You'll Be Doing

  • Responsible for development and management of the clinical sciences and medical writing team organization including processes, procedures, training, and activities that support planning, and execution of relevant departmental initiatives.
  • Lead development of sections of clinical study protocols (CSP), clinical sections of regulatory submissions/communications (IDE, PMA, 510k), clinical evaluation plans (CEP), clinical evaluation reports (CERs), post-market safety plan/reports (PMCFP/R), investigator's brochures (IBs), clinical study reports (CSRs), and evidence papers for submission support.
  • Oversee all aspects of publication and medical communication agencies/vendors including supervision and performance management.
  • Oversee conduct of targeted scientific literature searches, analyses of clinical/scientific data and competitive information across multiple products and/or therapies within the assigned therapeutic area.
  • Partner with Global and U.S. Regulatory Affairs; provide scientific input to support development of regulatory strategies for MicroVention products including oversight of clinical content development supporting Regulatory Affairs communications and overall initiatives.
  • Drive the generation of white and position papers by evaluating scientific literature, analyzing scientific data, and staying abreast of current clinical practice.
  • Assist Medical Affairs management with direct customer interactions as needed.
  • Perform additional responsibilities as assigned.The Skills/Experience Needed for the Role
  • Must have a Master's degree in a relevant science, medicine, or similar discipline with at least ten (10) years of relevant clinical, regulatory or medical affairs experience.
  • Proven track record in authoring complex scientific documents including Clinical Study Protocols, Clinical Evaluation Reports and Clinical Study Reports.
  • Experience in working cross-functionally internally and with external vendors and physicians in authoring clinical manuscripts for publication.
  • Excellent writing, editing and a keen attention to detail.
  • Strong verbal, written, and interpersonal communication skills.
  • Clinical protocol and evaluation report development experience.
  • Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.
  • Proven analytical skills working with clinical or research data.
  • Knowledge of Good Clinical Practices (GCP)What Will Differentiate You from the Crowd
  • MD/PhD degree in a relevant discipline with seven (7) years' experience in clinical research in the medical device/pharmaceutical/biotech industry.
  • Experience as an author or contributor of peer-reviewed manuscripts is strongly desired.
  • Knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology is desired.
  • Experience interacting with U.S. and global regulatory agencies highly preferred.What MicroVention Can Offer You
    • Great Places to Work Certified - 2022
    • Voted 100 Best Places to Work in Orange County - 2021
    • Competitive Benefits (Health, Eye, Dental)
    • Strong 401(k) with full vested status after 90 days
    • Comprehensive Talent Development Program
    • On-Site Full-Service Carwash every Tuesday (Aliso Viejo)
    • Free Electric-Car Charging Stations (Aliso Viejo/Tustin)
    • Tuition Reimbursement up-to $6,400/Year
    • On-Site Gym/Showers/Locker Room (Aliso Viejo)
    • Comprehensive COVID-19 Protocols
    • Community Service Opportunities
    • 15 Days of PTO and 15 Days of Vacation/Year (Paid 5-Day December Holiday Shut-Down)We are an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

Keywords: MicroVention-Terumo, Aliso Viejo , Sr. Manager, Global Clinical Science, Executive , Aliso Viejo, California

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