MSD Senior Specialist Regional Dossier Publisher - APAC 

Singapore, Singapore 

623034427

Job Description

Senior Specialist, Regional Dossier Publisher (RDP) – APAC

• Based in Singapore, the regional hub forAsia Pacific (AP)andtop-ranked biopharmaceutical company on the Straits TimesandStatista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join thepremier biopharmaceutical companythat has beenin Singapore for more than 25 years and in AP for over 60 years.

WHAT YOU WILL DO

Demonstrating a good degree of competence in regulatory affairs and understanding of dossier technical requirements within the region, this role provides technical subject matter expertise to support Country RA teams with their local publishing and agency submission transmission needs. This role is also expected to provide regional System Process & Regulatory Innovation (SPRI) support for identified GRACS RIIM tools, and partners closely with local, regional, and global stakeholders as well as domain experts within RRO to drive modernization of submission publishing processes in a holistic and integrated manner that keep pace with regulatory standards in a compliant manner. This role may be asked to participate in Inspections and Audits, to provide support, key metrics and to demonstrate core functionality of the tool(s).

• Utilize submission plans provided by Regional Regulatory Submission Planners to publish and deliver high-quality, agency-compliant regulatory dossiers that meet stakeholders’ timelines and perform subsequent dossier archival activities.
• Provide regional functional oversight to identifiedexternal publishing vendor partnerssupporting lifecycle management submissions within the region.

• Collaborate with other publishers within the internal team and across the regions on assigned products/projects and support other products/projects as needed to support priority and significant lifecycle submissions.
• Develop and maintain AP submission publishing templates based on country regulations.
• Provide technical subject matter expertise and associated trainings to relevant stakeholders in the publishing of agency compliant regulatory dossiers, including dossier structures and file formats, electronic submissions, and transmission (e.g., agency gateways), dossier repositories and databases.
• Keep abreast of internal and external regulatory procedures, guidelines, and policies, especially those that impact publishing activities, through self-directed learnings and participation in industry-wide discussions in partnership with other GRACS stakeholders as appropriate.
• For identified GRACS RIIM tools, provide direct support to system users within the region to build good data management practices e.g., timely and accurate data entry, explore and deploy automations for highly standardized and repetitive tasks, support additional system user trainings and system-process improvement collaborations.
• Participate in / organize in the Regional Communication forums to enable dissemination of knowledge on business processes and system changes that impact GRACS RIIM Systems.
• Where responsible for RIIM tools, represent the needs of the Region in different Change Control Boards, Communities of Practice, etc. to ensure that changes are appropriate for the region.
• Participate in system inspections and audits as needed, to provide support, key metrics and demonstrate core functionality of the tool.
• Drive modernization and innovation of regulatory submission publishing processes to improve efficiency and transparency through RIM tool optimization, work closely with local, regional, and global stakeholders and domain experts across departments and divisions.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelor’s degree in a science, information technology or Pharmacy discipline required.
• Minimum of 3-4 years’ experience in Regulatory Affairs, or 4 years’ experience in Regulatory Operations with good working knowledge of publishing requirements in the AP region and experiences with Liquent Insight Publisher and/or Lorenz DocuBridge.
• Detailed-oriented with the ability to work under tight deadlines and prioritize their own work across assigned projects and products.
• Ability to lead change, and influence others with broad organizational awareness and knowledge of touch points and interdependencies.
• Demonstrate problem solving skills within organizations and teams with experience analyzing information and developing actions to improve data quality and process or system improvements.
• Knowledge of the regulatory registration procedures in the AP region and other publishing tools will be beneficial.

Current Contingent Workers apply

Education

• Bachelor’s degree in a science, information technology or Pharmacy discipline required.

Required

• Minimum of 3-4 years’ experience in Regulatory Affairs, or 4 years’ experience in Regulatory Operations with good working knowledge of publishing requirements in the AP region and experiences with Liquent Insight Publisher and/or Lorenz DocuBridge.
• Detailed-oriented with the ability to work under tight deadlines and prioritize their own work across assigned projects and products.
• Ability to lead change, and influence others with broad organizational awareness and knowledge of touch points and interdependencies.
• Demonstrate problem solving skills within organizations and teams with experience analyzing information and developing actions to improve data quality and process or system improvements.
• Knowledge of the regulatory registration procedures in the AP region and other publishing tools will be beneficial.

Language

• Fluent in English and a regional Language, if applicable.

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.