• Join the premier biopharmaceutical company that has been in the Asia Pacific (AP) for over 60 years.

• Be part of best-in-class Medical Affairs Team and be at the center of innovation and excellence in execution.

Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.

What will you do in this role:

• Lead the Regional Scientific Operations Sub Team to provide operational support for assigning a variety related activities across AP countries.

• Global/regional/local medical & scientific affairs studies (including Local Data Generation (LDG), HECON, Post Approval Studies/Researches, Company Investigator Studies Program and In Scope Research Types (interventional or non-interventional), and Pre-License Patient Access (PLPA) Programs across ≥2 markets. Assist line manager in constructing and managing the Regional Scientific Operations team of in-sourced personnel. Train local field medicals/study leads on subjects related to study operations and corresponding SOPs.

Scientific Operations management expectations include:

• Develop, maintain, and monitor project plans, project schedules, budgets, and expenditures in compliance with local regulations and company SOPs and Policy.

• Organize and participate in project meetings (e.g., captures meeting minutes, tracks action items, contribute own perspectives, etc.),

• Proactively discuss with study leads and line managers to assess project risks and issues and provide solutions where applicable,

• Track project progress and provide project updates/summaries,

• Navigate internal processes and procedures, including compliance and finance, to ensure compliant execution of assigned projects,

• Ensure projects adhere to frameworks and all documentation is maintained appropriately for each project.

• Publication Tracking.
  

Medical Scientific Operations Management - Study Activities

• Lead and/or participate in the team to work with study lead to plan, initiate, conduct and manage a series of local/regional/global planned non-interventional studies with Global Medical Scientific Affairs and related Staffs:

• Lead and/or participate the team to plan, initiate, conduct and manage a series of local/regional planned Company Investigator Studies Program and In Scope Research Types (interventional or non-interventional) with Global Medical Scientific Affairs and related Staffs:

• Timely track the publication status of GMSA studies (submission time, acceptance/rejection, conference, journal).

• Publication includes conference poster, abstract, oral presentation and manuscript published in peer-reviewed journal.

• Regularly track and provide status updates to study leads and country medical directors, execute all study related administrative tasks, such as execute contracting and study payment, arrange study material allocation and delivery, arrange SIV/PI meetings, budget management and monthly accrual, etc.

Medical Scientific Operations Management - PreLicense Patient Access Programs (PLPA)

• Work with project lead to Implement and track GMSA-Owned PreLicense Patient Access Programs (PLPA) and ensure the execution quality, under the supervision of manager

• Conduct AE/PQC reconciliation process with GPV team to align with Global Pharmacovigilance Policy/SOP.

• Execute Good Documentation Practice through out for all GMSA studies, Events & activities and PLPA programs.

• Involve or/and conduct internal audit, inspections, and other quality assurance activities.

• Provide recommendation or trainings for continuous improvement, risk management control and knowledge transfer of Medical Scientific Affairs Projects within the company.

• Support Medical Scientific Affairs in driving operational excellence and help build the Regional Scientific Operations team structure.
  

What You Should Have

• Bachelor’s degree or Master’s Degree in pharmacy or related healthcare or scientific discipline.

• Experience 8 years+ experience within clinical/observational research or equivalent experience; 3 years+ of experience in project management, vendor management and budget-planning.

• Demonstrated pharmaceutical industry experience with a proven track record of leading large, complex, multi-stakeholder projects.

Core:

• Strong project management skills and sense of urgency

• Have ability to deal with ambiguity

• Clinical study execution related knowledge, including but not limited to GCP, GPP, IRB submission, HA submission, site initiation/close out, site management, liaise with vendors, budget planning/management, study drug import, specimen export, etc.

• Strong interpersonal, verbal, and written communication skills to work with medical and/or scientific teams

• Ability to independently handle multiple projects and priorities simultaneously and function in a fast-paced environment

• Experience working effectively both independently and as part of a team

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

• Self-motivation, flexibility, resourcefulness, and problem-solving capabilities, passion for science