管道MSL

PRIMARY FUNCTION:

Pipeline Medical Science Liaisons (MSLs) are key members of the affiliate medical department. These field-based roles focus on interacting with, and supporting the needs of, investigators participating in our enterprise critical (EC) studies. Pipeline MSLs work to communicate information and facilitate scientific dialogue about AbbVie’s investigational products, and compounds in development, in a strictly scientific, non-promotional manner, and in full compliance with applicable national laws and regulations, guidelines, codes of conduct, AbbVie’s policies and procedures (see Note 3, below) and accepted standards of best practice.
Pipeline MSLs serve to enhance the scientific credibility of the Company with established and emerging clinical investigators as well as key scientific institutions and collaborative study groups, by supporting scientific dialogue and collaborations in the areas of research, medical and scientific exchange, including facilitation of requests for scientific and medical information. MSLs also participate in close partnership with affiliate-based Clinical Site Monitoring (CSM) staff in the initiation, oversight, and follow-up of clinical studies. They also interface with other key members of the affiliate medical department - for example: Medical Managers, Medical Advisers, Clinical Research Associates and functions such as Health Economics and Outcomes Research, Market Access and others as appropriate - relevant to the therapeutic area for which the MSL has responsibility and work collaboratively and cross-functionally with other in-field members while retaining functional independence. They maintain a high level of scientific knowledge to ensure credible dissemination of scientific information and informed scientific dialogue with key external stakeholders.
Notes:

• Medical Science Liaison is used as a general term in this document, and may also encompass other specific job titles, such as, but not limited to: Medical Liaison, Scientific Project Manager, Science Specialist, and Clinical Science Manager.

• Refer to Appendix 1 of this document. In addition, definitions of the Tier Structure for thought leaders can be found in the Appendix to this Job Description.

• An Acceptable Practices Policy exists in all affiliates, and governed by the Affiliate Compliance Committee, to describe activities permitted by this role.

• This Job Description does not apply to those employees whose primary job function relates to the monitoring or management of clinical studies.

RESPONSIBILITIES:

• Ensure a strong medical and scientific presence for AbbVie in investigational sites and key scientific centers by facilitation of clinical research and of interventional phase 1-3 trials with AbbVie drugs, while supporting requests for medical and scientific information on products or areas of therapeutic interest to Abbvie

• Establish and maintain a close working relationship with CSM staff and partner in facilitating the initiation and conduct of prioritized Abbvie-led clinical trials.

• Provide scientific and technical leadership to ensure professional and credible relationships with investigators.

• Consult with physicians, pharmacists and other medical professionals to refer appropriate patients to Clinical Trial sites and review clinical practice topics as requested by the investigator or referring sites.

• Act as the point of contact with thought leaders to facilitate investigator-initiated study (IIS) ideas with AbbVie pipeline assets and requests for support to the local and global medical teams as appropriate.

• Deliver credible presentations on scientific matters in the disease area of responsibility and about AbbVie’s pipeline to investigators in Abbvie-sponsored interventional research.

• Participate in the selection process to identify appropriately qualified external experts the Company would wish to engage in collaborative efforts – such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.

• Identify opportunities for R&D collaborations with key institutions and thought leaders and liaise with the Search& Evaluation team and Discovery or Clinical Development teams to facilitate further assessment.

• Facilitate medical and scientific field intelligence – for example, maintain a list of investigators/potential investigators within a given TA, understand competitive research activities in active or planned study sites, generate insights from investigators on challenges and opportunities for AbbVie-sponsored clinical trials – and communicate, where appropriate, within the Company.

• Attend relevant scientific meetings and Conferences.

• Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.

• For countries involved in the 1-7-5 early touchpoint process: provide insights on the current clinical practice, facilitate identification of tier 1 external experts and provide scientific input into the future clinical development program for AbbVie’s pipeline assets.

• Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.

ACCOUNTABILITY & SCOPE:

• Provide scientific and technical input to local AbbVie study teams, (early) brand teams and external investigators using information that has been reviewed and approved by relevant local procedures, and under the direction, governance and oversight of the MSL’s manager, therapeutic area Medical Manager, or Affiliate Medical Director as appropriate. This includes working with local Medical Information teams, as appropriate, to respond to unsolicited requests for off-label information on AbbVie medicines.

• Ensure adherence to all applicable national laws and regulations, guidelines, codes of conduct, AbbVie standards, policies and procedures.

• Develop and maintain collaborative relationships with investigators and thought leaders in the product / therapeutic area for which the MSL has been assigned responsibility, to facilitate Abbvie research and contribute to the success of our pipeline.

IDEAL CANDIDATE:

• Advanced degree (e.g. PharmD., MD, PhD) in a relevant scientific discipline is strongly preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.

• Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general.

• Professional experience as MSL or CRA or in a similar field-based R&D role for at least two years.

• Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.

• Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.

• Ability to comprehensively learn about new subject areas and environments.

• Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians and other healthcare decision makers.

• A good understanding of written and oral English is desirable.

• High customer orientation.

• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Originally posted on Himalayas