Medical Affairs Manager

Abbott Laboratories; Petaling Jaya; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a Medical Manager to oversee medical affairs and clinical research initiatives. The ideal candidate will provide medical expertise for promotional materials, ensure compliance with regulations, and manage relationships with key opinion leaders. A medical degree and experience in medical affairs are essential for this role.

Qualifications

• Proven experience in medical affairs and clinical research.
• Strong understanding of compliance and regulatory requirements.
• Ability to communicate scientific and clinical information effectively.

Responsibilities

• Provide medical expertise to promotional materials.
• Oversee medical aspects of brand team interactions.
• Lead clinical study activities to ensure compliance with regulations.

Skills

Medical expertise

Regulatory knowledge

Pharmacovigilance

Clinical research

Communication skills

Education

Medical degree

Job description

Primary Job Function:

• The Medical Manager is accountable for providing input into the development and delivery of a strategic, regionally and globally aligned medical activity plan in Malaysia in order to deliver improved therapeutic benefit for the patient.
• The incumbent will be responsible for Affiliate Medical Affairs, Clinical Research and Pharmacovigilance activities and will be a medical subject matter expert supporting Regulatory Affairs, Business Development, Quality Assurance and Commercial when necessary.
• This position coordinates and executes local medical and clinical research initiatives, enables and assists the affiliate to provide quality local medical services to EPD Strategic Medical Affairs (SMA).

Core Job Responsibilities:

Oversee medical aspect of brand team interactions

• Provides medical subject matter expertise to promotional material development and other commercial and marketing initiatives
• Reviews material and projects to ensure scientific alignment and compliance with good promotional practice
• Signs off for medical review of promotional materials
• Acts as affiliate signatory on relevant documents where required.
• Provides medical support to the marketing and product planning groups for new products, line extensions, and new indications.
• Support launches by engaging external KOLs to gather insights, providing scientific evidence trainings and creating promotional materials with commercial colleagues.
• Serves as a point of medical query answer provider on queries received from external key stakeholders (e.g. KOLs, doctors, allied healthcare professionals etc.) and internal stakeholders (e.g. other functions QA, RA, PV, commercial team etc.)
• Creates or modifies slide decks for external stakeholders to use for disease talks during local scientific meetings/discussion forums/formulary submissions.
• Provides training and refresher course on therapeutic area when requested by internal stakeholders.
• Conducts medical/marketing activities that increases capabilities of internal sales force (e.g. journal clubs)
• Leads and facilitates scientific discussion between Abbott staff and external KOLs on Abbott related products and therapeutic areas.

May Serve as Affiliate Safety Representative or “back-up Affiliate Safety Representative”

• Supports implementation of effective Pharmacovigilance systems operating within the affiliates, and that reporting requirements to competent authorities for adverse events and other safety related documents are adhered to.
• Proactively anticipates possible safety signals and communicate appropriately according to standard procedures

Lead affiliate and Subregional Clinical Research

• Initiates discussion/meetings and co-write research protocols with external KOLs on scientific topics of interest to further Abbott products reach to the scientific community.
• Oversees clinical study activities of the affiliates to ensure compliance with corporate Standard Operating Procedures SOP’s, GCP, and local regulatory requirements pertaining to the conduct of clinical studies.

Support Medical Governance

• Accountable for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.