Medical & Regulatory Affairs Assistant

[Summary of Role]
To support the effective and quality operations of diverse events and activities held in Medical Affairs and ensuring administrative processes are kept in compliant way.
This position is within Medical Affairs Department, however, for optimal resource management of the organization, this incumbent partially supports Regulatory affairs tasks.

[Job Information]
- Direct Contract (Maternity/childcare leave replacement)
- Expected contract duration : 18 months (possibility of additional 6 months contract extension)

[Responsibility]

I. Medical Affairs

• Support Medical Affairs Activities(ABMs, medical symposium, clinical studies, grants, sponsorship through KRPIA, etc.) to be operated smoothly and with high quality

• Lead the vendor management (bidding, registration, deletion) and be the point of contact for the 3rd party vendors

• Medical event management including but not limited to, contract, payment, archiving and reporting for transparency

• Management of Study contracts and payments, especially Investigator Sponsored Study(ISS), and closely communicate with the Study Coordinators at the hospital/investigational center

• Company seal custodian for Medical (and Regulatory Affairs)

• Manage SPEX(Speakers list) system including the obtaining of necessary documents (DOI/CV/SPEX request form), archiving and folder management, monthly reconciliation and annual revisits

• Be the ambassador for Transparency in close collaboration with Compliance & Legal partner: track, monitor and support regular reporting of speaker/consultant fees to KRPIA/MOHW

• Support generating priodic reports for Medical Information and Promotional material review/approval(PMRA)

• Back up of Medical Information calls in vacancy of MI Officer, as described in the SOP

II. Regulatory Affairs

• Quality complaint administration:

• Preparation of complaint report, defective sample delivery to HO and related document management/archiving

• Preparation of PV reconciliation

• Quality Assurance support:

• Preparation of document (Receipt approval form, Batch release form, Sample receipt form, Re-dressing request form)

• Request quality control test to external partners and update the record

• Archiving original documents of Quality control records for all Servier Korea Product.

• Document management (disposal of expired documents)

• Preparation of packaging materials documentation for new batches of all Servier products

• QC Reference Standard management

• Regular checks of stock level, ordering and delivering Reference standards to QC lab

• Communication between Hanwha QC lab and HO (Re-test CoA request)

• Administrative supports: MFDS submission fees, patent fees, recycling charge to Korea Environment Corporation and etc.

• Support for renewal of trademarks license agreement between the HO and licensees

[Requirement]

• Basic qualification

• graduate degree (Bachelor) is required, biosience background is preferred but not a must

• Experience

• More than 2 years of professional experience, preferably in a multinational pharmaceutical company or in relevant functions in the industry (eg. Contract Research Organization, KRPIA, KoNECT, etc.)

• Knowledge of the pharmaceutical environment and understanding of the role of Medical Affairs to advance the medical and scientific objectives of the organization

• Required skills

• Ability to prioritize and handle complex situation and projects

• Excellent written and spoken communication skills, in both Korean and in English

• Business acumen

• Strong commitment to compliance with the relevant rules and procedures and high work ethic standards

• Good interpersonal skills and emotional intelligence