Enterprise Research MSLs are key members of the US medical department. These field-based roles focus on interacting with, and supporting the needs of, investigators participating mainly in Enterprise Critical Studies. Enterprise Research MSLs work to communicate information and facilitate dialogue about AbbVie’s investigational products, and compounds in development, in a strictly scientific, non-promotional manner, and in full compliance with applicable laws and regulations, guidelines, codes of conduct, AbbVie’s policies and procedures (see Note below) and accepted standards of best practice.
Enterprise Research 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. Enterprise Research MSLs also participate in close partnership with Site Management & Monitoring staff in the initiation, oversight, and follow-up of clinical studies. They also interface with other key members of US Medical Affairs (e.g. Medical/Scientific Directors, other MSLs, US Medical Operations), other Clinical Research functions such as Health Economics and Outcomes Research, Clinical Development, and others as appropriate - relevant to the therapeutic area for which the pMSL 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.
- Ensure a strong medical and scientific presence for Abbvie in Enterprise Critical investigational sites and key scientific centers by the facilitation of clinical research in 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.
- Engage with Clinical Trial Site Investigators and Staff to understand enrollment/screening barriers from a medical perspective and work with the site and AbbVie to find potential medical solutions. Aiming to support clinical trial enrollment.
- Establish and maintain a close working relationship with Site Management & Monitoring 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, in compliance with relevant laws and regulations, 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 for investigator-initiated study (IIS) ideas with AbbVie Enterprise Research assets and requests for support with the USMA TA MDs and the global medical teams as appropriate.
- Deliver credible presentations on scientific matters in the disease area of responsibility and about AbbVie’s Enterprise Research to investigators in Abbvie-sponsored interventional research.
- May participate in the selection process by suggesting sites and investigator names to help 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 External Experts 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 and may represent AbbVie in scientific booths at congresses.
- 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.
- May contribute to the AbbVie’s 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 Enterprise Research 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:
- Support Enterprise Critical Studies’ related activities from a medical affairs perspective and contributing to meeting study timelines.
- 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 pMSL’s manager, therapeutic area the USMA TA MDs and the global medical teams 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 pMSL has been assigned responsibility, to facilitate Abbvie research and contribute to the success of our pipeline.
INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:
- US medical affairs personnel: Clinical Research Associate, Local Study Representative, Clinical Operations Manager, Medical Directors; Medical Information team / specialists; pharmacovigilance / drug safety personnel
- Market access teams incl. HTA teams; US Early Brand teams.
- US Government Affairs; US Public Affairs; Regulatory Affairs; Legal; OEC.
- Global Medical Information.
- Regionally and HQ based Therapeutic Area Medical Affairs teams.
- Project/Medical Directors and Clinical Teams within Pharmaceutical Development and Global Medical Affairs.
- Healthcare personnel (including physicians, nurses, pharmacists).
- Participating Research Investigators; thought leaders/external experts.
- Institutions and Scientific or Medical Societies.
- Hospitals, other healthcare providers, payers, and Local Regulatory Authorities.
AUTHORITY AND REPORTING LINES:
- This position typically reports into the Enterprise Research/Field Director.
- 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 HCP orientation.
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
重點工作內容: Driving a personal auto or company car or truck, or a powered piece of material handling equipmentKeyboard use (greater or equal to 50% of the workday)
出差: Yes, 75 % of the Time