Medical Manager MYSG

Global Travel & Expense Team Lead

Lead Quality Specialist - Investigator

Responsibilities: <ul><li>Develop and maintain for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self study of the national/Area literature.</li><li>Provide expert medical/scientific advice for assigned products and related therapeutic areas, including responding to requests for scientific/technical information; contribute to the development and medical and scientific accuracy of core dossiers generated by the medical department (i.e. HEOR dossiers, medical information packs, clinical expert reviews etc.).</li><li>Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.</li><li>Establish and maintain professional and credible relationships with doctors / external experts and academic centers; this will involve participating in scientific congresses, coordinating advisory boards, round-table meetings, discussion fora etc.</li><li>Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups (meetings, clinical sessions, etc.), where appropriate.</li><li>Screen relevant literature and other information from relevant scientific societies meetings and conferences and develop summaries of key messages for use within the Company (e.g. key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc.)</li><li>Deliver training to sales forces and other departments; develop and update relevant training materials.</li><li>Involved in the Medical/Brand planning process and to ensure that all planned projects/Scientific activities are carried out, ensuring all budgets, timelines and</li><li>compliance requirements are factored into the completion of projects.</li><li>Provide the required oversight to manage review, approval and conduct of investigator-initiated studies.</li><li>Review and preparation of promotional/ Non-Promotional material. Ensure the medical/scientific content is correct and fully compliant with PhAMA and SAPI code of practice.</li><li>Provide medical/scientific input into marketing strategy and key commercial initiatives, as required. Monitor the environment for competitive intelligence (e.g. product strategies, studies, commercial messages, positioning, etc.) and communicate, where appropriate, within the Company.</li><li>Responds to HCP’s medical enquiries and co-lead PV initiatives with the country Regulatory team.</li><li>Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, policies and procedures and accepted standards of best practice.</li></ul> Requirements: <ul><li>Has a medical degree</li><li>Minimum 1-2 years post-qualification work experience in Medical Affairs function.</li><li>Experience working within the pharmaceutical industry or within clinical research is preferred</li><li>Experience working collaboratively and cross-functionally in a matrixed structure, supporting multiple stakeholders</li><li>Demonstrated ability to learn quickly and convey clinical and non-clinical technical information effectively to individuals with varying degrees of scientific acumen.</li><li>Demonstrated strong presentation and teaching skills with ability to effectively share information with others</li><li>Demonstrated ability to develop and maintain strong relationships; to lead &amp; engage</li><li>Experience applying analytical skills, to critically evaluate and effectively communicate key clinical data</li><li>Experience working with technology, including systems such as Microsoft Office</li><li>Role is based in Malaysia; covers to countries: Malaysia (60%) and Singapore (40%)</li></ul>

Responsibilities: <ul><li>Responsible for direct oversight of the Travel and Expense programs, owning and driving both the daily operations and the global strategy for the programs</li><li>In depth understanding in SAP concur expenses and has subject matter expertise in driving concur deployment</li><li>Collaborative relationships with key stakeholders to resolve issues, recognize opportunities, and drive continuous improvement using design-thinking and customer centric mindset</li><li>Business requirements for concur implementation and playing a key role in the implementation of Concur, including system configuration, user training, and change management.</li><li>Fraud detection and implementation of solutions such as Concur detect</li><li>Resolution of queries raised by team members and work closely with cross functional teams /project team /IT team for resolution</li><li>Identify areas for improvement and suggest strategies to optimize expense reporting processes</li><li>Stay updated on global policies, regulations, and best practices related to expense reporting and Concur</li><li>Other duties as assigned</li></ul> Requirements: <ul><li>Coaching the team and providing ongoing support and troubleshooting for concur related issues and strong accounting knowledge</li><li>Has strong experience in ERP migrations and decommissioning activities and hands on experience on SAP and JDE</li><li>Experience in identifying inefficiencies in T&amp;E systems and leading projects to improve policies and processes.</li><li>Hands on experience in report building using Cognos reporting tool and other analytical tools</li><li>Strong people management skills, with the ability to motivate, develop, and mentor a team.</li><li>Excellent people management skills</li><li>Other duties as assigned</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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3 fraud investigator Jobs found

Medical Manager MYSG

Global Travel & Expense Team Lead

Lead Quality Specialist - Investigator

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Medical Manager MYSG

Global Travel & Expense Team Lead

Lead Quality Specialist - Investigator

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