Total 1 quality assurance manager job vacancies in d18 tampines pasir ris

POSITION SUMMARY:

As part of the Regional Medical Affairs Team, the Regional Medical Affairs Manager will act as the regional therapeutic expert for our Consumer Health, Pain and CNS portfolios (subject to be updated as for business and medical needs). This role will also be responsible for clinical operations, real world evidence such as CRO management, clinical trial documents and clinical operation support to affiliates. In addition, this role will support on medical operation and compliance activities (RMA audits, digital initiatives, SOP knowledge).

KEY RESPONSIBILITIES:

Medical Affairs

• Provide medical and scientific support.
• Act as the regional therapeutic expert for assigned therapeutic areas. Provide Medical affairs support to local affiliates where there is no medical presence as required.
• Work in collaboration with the regional marketing teams and provide strategic medical input into core brand strategies and support medical marketing activities such as promotional material, product launches, omnichannel engagement, brand planning, etc.
• Perform medical assessment for the respective brands for business development opportunities as well as other assets as assigned
• The regional medical point of contact for the TAs for the regional and local medical and marketing teams for providing directions and support on medical action items, including but not limited to KOL engagements, insight seeking, advisory boards, Medical led meetings and initiatives, patient centricity, medical omnichannel communications, etc.
• Manage medical information inquiries for the assigned therapeutic area.
• Conduct regional scientific training on the disease and products.
• Lead life cycle management and data generation activities for the regional/corporate brands.
• Support the building of strong regional advocates and expert panels and speakers for the brands.
• Maintain knowledge of relevant regulations and guidelines and disseminate same to clinical project teams.
• Research and prepare training on therapeutic areas and indications of relevance and maintain an awareness of trends and changes of importance in the management of those indications.
• Initiates and maintains interactions with key opinion leaders and investigators in therapeutic areas of interest. Create and implement KOL mapping and engagement plan.
• Attend and act as an advisor to relevant clinical development projects or clinical meetings.
• Create or support the development of medical/scientific materials and slide decks as needed and ensure the content is reviewed and approved.
• Act as backup for pharmacovigilance case assessment as needed. Work together with the Pharmacovigilance team to perform adverse event causality assessment for local, regional and global products as well as partner products

Clinical Operations:

• Leads all stages of the clinical study development process including: feasibility assessments; protocol design; CRF design; ISF investigational site selection; generation of clinical study reports and the development of study-related documents, informed consent documents, study manuals and plans, trial master files (TMF), case report form design, etc. Identify data gaps and the need for phase 4 RWE studies for data generation.
• Provide clinical operation support to the local team as needed.
• Act as regional medical lead for CRO management, conduct due diligence for onboarding of the CRO and participate in CRO qualification and audit process.
• Work closely with CRO and keep track of project timeline, budget and milestones.
• Takes responsibility for and initiates the review of all clinical study documents and reports such as project management plans, data management plans, interim reports, etc.
• Work closely with the regional medical director/associate director to study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
• Proactively identifies and resolves issues, and participates in process improvement initiatives as required.
• Reviews and approves invoices from study vendors, investigators, consultants, etc. and planning of the clinical study budgets.
• Oversee medical aspects of the risk management and risk mitigation strategies.
• Act as data manager to ensure the correctness of the clinical study data and verify the statistical analysis.
• Present clinical study data at regional and global conferences as a poster or oral presentation.
• Work with regional TA lead, regional marketing team, local medical team, and local marketing team on the dissemination of the clinical study data; participate/organize investigator meetings, steering committee meetings, and interdepartmental meetings.
• Ensures GCP, regulatory compliance, internal SOPs and working instructions are maintained throughout the clinical study lifecycle.

KEY REQUIREMENTS:

• At least 5 years of medical affairs and clinical research/development experience within a pharmaceutical or Biotechnology Company.
• A certified Doctor (MBBS, MD) or a post-graduate scientific degree in medicine, biology, PhD, etc. will be an advantage.
• Solid understanding of medical affairs in the pharmaceutical industry with the ability to connect medical affairs and commercial priorities to work with cross-functional stakeholders as well as experience in people management and project-based activity and successful delivery of initiatives are required.
• Excellent written and verbal communication skills and good presentation skills.
• Travel to markets within APAC would be required.
• Strong Commercial awareness - Ability to work with regional and local commercial stakeholders.
• Unquestionable integrity and positive attitude.
• Great at building relationships, particularly with KOLs.
• Willing and capable of managing multiple projects, tight timelines and responsibilities.