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Sr. Manager, Global Medical Information

Location San Rafael, California

JOB DESCRIPTION

Job Title:

Senior Manager

Department / Cost Center:

Global Medical Affairs (GMAF) Global Medical Information (GMI)

Reports to (Job Title):

Job Code:

Location:

San Rafael

Date Prepared:

Full-Time     Part-Time

Regular     Temporary

Exempt     Non-Exempt

OVERVIEW:

BioMarin Global Medical Affairs, Global Medical Information

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.

Global Medical Affairs (GMAF) is an expert scientific and medical function that develops and maintains non-promotional, evidence-based, transparent and balanced scientific and educational programs and resources in support of BioMarin’s products and disease states of interest. We do this by assuring safe and appropriate product use, support of continuous scientific exchange and through ongoing and new data generation.

Within BioMarin GMAF, the Global Medical Information (GMI) group is responsible for the management of Medical Information services related to BioMarin’s marketed and pipeline products. The primary functions of the group include inquiry intake and response, maintenance of medical information databases, and coordination of Medical Information conference participation. GMI also manages processes related to REMS and oversees the US/Global programs’ Continuing Medical Education (CME) grant process.

SUMMARY DESCRIPTION

The Sr. Manager position is an early leadership role within GMAF Global Medical Information focusing on ensuring high quality medical information outputs. The Sr. Manager is responsible for standard responses, FAQs, and slide decks of increasing complexity, and may take a leadership role in Medical Affairs congress participation. S/he may lead departmental process improvement initiatives. The Sr. Manager is developing skills related to the mentorship of more junior staff as well as the leadership of more complex projects.

The individual in this position exhibits advanced skills across several core and technical competencies, including communication, adaptability, therapeutic area, and organizational enterprise agility.

KEY RESPONSIBILITIES: Global Therapeutic Area Lead

Global responsibility across therapeutic area, including but not limited to:

  • Develop, maintain, and facilitate approval of Global Medical information content for internal and external audiences, including:
    • FAQs, standard response letters (SRLs), and custom responses
    • Slide presentations for assigned TAs, including master decks and launch decks
  • Act as a subject matter expert for internal and external customers for assigned TA, and responsible for staying up to date on and assessing impact of latest publications and events related to assigned TA
  • Manage and monitor GMI cases for assigned therapeutic area
  • Lead and/or support Medical Affairs booth pre- and post-congress activity, including preparation and shipment of congress materials, coordination of congress planning meetings, booth staffing, and ensuring content management system is in place for relevant and assigned congresses
  • Support training of regional new hires and business partners, including presentation development to ensure understanding of the process for submitting Global Medical Information requests
  • Support global competitive intelligence initiatives by gathering and sharing TA  and /or competitor information, if requested
  • May support assessment and planning for regional CME conferences
  • Represent as GMI lead on GMAF and cross-functional teams, including contributing presentations and sharing content at Matrix team, Pub Planning, Commercial, and other internal product team meetings
  • Review accuracy of materials for assigned TA, including medical materials review committee (MMRC) and promotional review board (PRB) materials
  • Support efforts to ensure compliance with relevant systems and regulations for assigned TA and other areas as requested
  • In coordination with other departments, participate in special teams for cross-functional projects
  • Share metrics and post-congress updates at brand team and Matrix team meetings
  • Participate in training and oversight of vendors for assigned TA and special projects
  • Support internal projects and organizational change initiatives as requested

KEY RESPONSIBILITIES: Regional Lead

Regional responsibility across multiple products, including but not limited to:

  • Adapt and customize Global Medical information content for regional customs, language, and sensitivities, including:
    • Standard response letters, FAQs, and customized responses
    • Slide presentations for products, including master decks and launch decks
  • Liaise with the Global Therapeutic Area Lead on content development and approval for response documents
  • Collaborate and liaise with relevant regional medical and commercial teams to ensure accuracy and consistency of interactions and completeness of responses
  • Lead and/or support Medical Affairs (GMAF) congress activity regionally, including preparing and staffing booths, participation in congress planning, preparation and shipment of materials, and supporting content management systems
  • Support global competitive intelligence initiatives by gathering and sharing product, disease, and /or competitor information, if requested
  • Manage regional customer service department
  • May support MMRC and PRB materials review for assigned region
  • Ensure compliance with relevant systems and regulations in assigned region and other areas as requested
  • Share metrics and post-congress updates at brand team and Matrix team meetings
  • Participate in training and oversight of vendors for assigned region and special projects
  • Support internal projects and organizational change initiatives as requested
  • Attend local industry trade groups and meetings to build subject matter expertise
  • Keep abreast of regional guidelines and regulations and communicate learnings to team

COMPETENCIES

A Senior Manager demonstrates advanced core competence in communication and adaptability. This includes (but is not limited to):

  • Adapting communication style, message and delivery method and medium to audience; knows when to ask for guidance on complex or difficult messages
  • Proactively expanding network and work relationships outside department and company, building more influential, productive relationships
  • Adjusting to and communicating updated work priorities to meet changing goals or tasks and encourage others to do the same

S/heis also expected to demonstrate advanced technical skills in drug development, therapeutic area knowledge, organizational enterprise agility, and scientific interpretation. This includes (but is not limited to):

  • Demonstrated understanding of how trial(s) and drug(s) fit into BioMarin therapeutic area strategy
  • Comprehensive understanding of study protocol objectives, scientific rationale, methodology, procedures, clinical impact, and data analytics
  • Ability to leverage nuanced understanding of the nature and implications of BioMarin matrix organizational structure to find information, including through creative and non-traditional avenues when necessary
  • Ability to leverage an understanding of medical literature, scientific committee requirements, and best practices to effectively review references for appropriateness and applicability

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GMAF has been defined and is available to employees of BioMarin.

PEOPLE MANAGEMENT

The Senior Manager is expected to manage up to 2 direct reports; actual number of direct reports may vary depending on business needs

EDUCATION AND EXPERIENCE

  • BA/BS in life sciences, health sciences, or other technical area. PharmD or advanced health sciences degree preferred. Industry or relevant experience in lieu of education accepted.
  • 6 or more years of relevant experience in medical affairs, clinical sciences or practice, business, and/or equivalent field
  • Some line management experience (0-1 years) preferred

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 20lbs. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions.

CONTACTS

Internal:Clinical Operations, Pipeline Commercialization, Market Access, Medical Communications, Regulatory Affairs, Patient Advocacy, Medical Directors and Medical Science Liaisons, Medical Information, Legal, Corporate Ethics & Compliance, Corporate Communications, Pharmacovigilance, Biometrics, Development Sciences Quality (DSQ), Business Operations

External:Clinical Trial Site Staff, vendors and suppliers

About our location

San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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