Senior Medical Affairs Manager

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.

Position Accountability/Scope:

Products/Therapeutic Areas:

• All EPD products and therapeutic areas, including those that are unique to the affiliates within the sub-region

Key Internal Contacts (not limited to)

• Affiliate staff across commercial and support functions (RA, QA, Finance, HR, Legal, Business Development, Public Affairs among others)
• Regional and area management team
• Global Strategic Medical Affairs Management
• Global Clinical Development Management
• Regional PV Director

Key External Contacts (not limited to):

• Scientific community: KOLs, Investigators, Advocates
• Business partners: contractors, consultants, vendors

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

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