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Mgr, Medical Affairs -- Enterprise Medication Mgmt

Apply Now Job ID R-356932 Date posted 01/15/2020

Locations

San Diego, California

Job Description Summary

Job Description

Functional/Organizational Summary

Medical Affairs (MA) has a critical role in new product development, to include Key Opinion Leader engagement on innovative technologies; user needs, requirements, and hazards, all to ensure product safety and efficacy. MA also plays a large role in the development of post market risk estimation criteria, risk benefit analysis of products, Clinical Evaluation Reports and literature searches.

Position Summary 

The Manager, Medical Affairs is responsible for overseeing and managing both the clinical and administrative aspects of the medical division of business. This includes innovation and new product/business development, lifecycle clinical evidence generation, market shaping and development, and safety and compliance.  The position may directly or indirectly (matrix) manage professional employees, business support, or technical staff. 

Job responsibilities:

  • Develops processes and procedures to implement Medical Affairs strategies, including the execution of business operating plans.
  • Accountable for setting own work direction and completing work tasks assigned by leadership team.
  • Has accountability for good stewardship of financial resources for personal and project expenses.
  • Innovation: Based on specialized training & clinical operations experience, serves as the internal “Voice of the End User” to help ensure that products released to market are safe and effective.  Includes: Core Team representation, Extended Core Team leadership for medical workstreams, and provides subject matter expertise (SME) input to Research & Development (R&D)/User Experience Design (UXD) on clinical operations and outcomes topics.
  • Evidence generation: For assigned areas of responsibility, serves as the organizational leader responsible for developing & overseeing evidence generation activities, leading publication and dissemination strategy, and ensuring clinical trial excellence.  Includes: study protocol development, evidence project execution, and presentation of study results at internal leadership and external professional meetings.
  • Market shaping: Engages Key Opinion Leaders (KOLs), customer SMEs, and other external stakeholders and recommends clinical practices to improve outcomes and patient safety.  Includes: support/develop KOL panels and other engagements; support implementation of evidence for customer-facing materials and engagements.
  • Safety and compliance: supports activities ensuring safety and compliance throughout product lifecycles; supports enterprise-wide medical policies and procedures; ensures medical and clinical claims accuracy.  Includes: serving as the Medical Affairs clinical delegate and attending Risk Management Board (RMB) meetings for the assigned product line.
  • Performs other duties and assignments as required.

Professional Skills & Key Competencies

  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
  • Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
  • Demonstrated organizational, planning, and project management skills, including action oriented, focused urgency, and driving for result.
  • Ability to be effective in complex projects with ambiguity and/or rapid change.
  • Orientation for detailed work product, with emphasis on accuracy and completeness.

Minimum Education Qualifications & Previous Experience:

  • Must have a Pharmacy degree (PharmD) 
  • Highly preferred: Advanced degree (MS, MBA, etc.).
  • Must have minimum 4 years practice experience as a licensed pharmacist in an enterprise healthcare system setting.
  • Must have Pharmacy practice (PGY-1) residency training
  • Highly preferred: Specialty pharmacy practice (PGY-2) residency training
  • Highly preferred: Experience directly or indirectly (matrix) managing vendors, cross-functional project team members, and has medical process/program management/ownership.  This includes project leadership, employee coaching, mentorship, and supervision of support and entry-level professional associates.
  • Preferred: Ability to apply expertise to improve effectiveness and provide clinical and technical guidance to employees on the team.
  • Highly preferred: Knowledge of and experience using and interpreting basic biomedical statistical methods.
  • Must have conducted literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results.
  • Must have exposure to participating in and/or managing investigational drug or medical device studies, including conducting literature reviews, study design and execution, and compliance monitoring.
  • Must have experience in continuous process improvement projects and project management.
  • Must have prior clinical practice experience with BD product categories.
  • Preferred: Prior people management, ideally in a matrix environment.
  • Preferred: Prior experience with medical product development.
  • Highly preferred: Demonstrated excellent verbal and written communication skills, including the ability to write scientific papers and present at professional conferences.
  • Must have working experience with multi-disciplinary/cross-functional teams.
  • Highly preferred: Comfortable working in a position that requires flexibility within a fast paced, multi-task matrixed environment.

Any Additional Information

  • Travel may range from 15-25%, overnight travel. 
  • Position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities.

#LI-TECH

Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

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