MWM (Medical Writer Manager)

[담당업무]

• Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work.

• Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in

 conjunction with Human Resources and training plan.

• Ensure that staff have the proper materials, systems access and training to complete job responsibilities.

• Provide oversight for the execution of the training plan, SOP complete and review.

• Participate in the allocation of resources by assigning staff to clinical studies that are appropriate to their experience and training.

• Prepare, review or approve Sample Size and Power Calculation of Clinical Trials.

• Support and review study documents in related subjects, such as protocol, CSR etc.

• Responsible to reply questions from the sponsor and authorities etc.

• Support project inspections and audits

• Maintain good cross function and external customer relationship (include the sponsor, investigators and regulatory authorities, etc.)

• Other tasks assigned by the line manager

[지원자격]

• Clinical or relevant experience is preferred.

• 8 year pharma or CRO experience is preferred.

• Familiar with GCP and other related regulations and guidelines.

• Good therapeutic area knowledge.

• Good in MS-office.

• Good interpersonal and communication skill, able to work effectively

with different levels in the organization.

• Problem-solving capability.