AbbVie LATAM Therapeutic Area Lead - Director - Rheumatology in Brazil
LATAM Therapeutic Area Lead - Director - Rheumatology
4 additional locations
USA, Puerto RicoMexicoColombiaArgentina
ATTENTION: This position requires green card and it is located in Lake County, IL - US
Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety. Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
•Develops, reviews and follows up on clinical studies and medical projects initiated within the relevant therapeutic area (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.) at the regional/local level.
•All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
•Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
•May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
•May assist in scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
•Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
•May represent the medical function on cross-functional integrated teams for medical affairs 'activities. May represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
•May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
•May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
•Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.
•Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Completion of residency and/or fellowship is preferred.
•National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred.
•Medical Affairs experience in pharma with therapeutic experience in rheumatology, dermatology or immunology preferred.
•Minimal clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
•1-2 years of experience is preferred.
•Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
•May possibly have performed protocol design in the academic environment or in the pharmaceutical industry and/or acted as an assistant PI or PI.
•Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects/schedules, etc.
•Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
•Ex-Us: At least one further major international language (Spanish and/or Portuguese) is preferred.
Significant Work Activities and Conditions: N/A
Travel: Yes, 15 % of the Time
Job Type: Experienced
Shift: Day Job
Job Level Code: IC