Associate Regulatory Affairs Manager Ah jobs at Msd in Taiwan, Taipei
MSD Senior Product Manager - PAH/Rare Disease Taiwan, Taipei
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Job Description
Role & Responsibilities
- Strategic Planning: Develop and execute the product launch strategy, including market analysis, positioning, and competitive landscape assessment.
- Cross-Functional Leadership: Collaborate with regulatory, market access, policy shaping, supply chain, sales, and medical affairs teams to ensure alignment and successful execution of the product strategy.
- Innovative Marketing Solutions: Design and implement innovative marketing strategies and campaigns tailored to the unique needs of the cardiology and rare disease markets to fulfill patients/HCPs’ needs.
- Stakeholder Engagement: Build strong relationships with key opinion leaders, healthcare professionals, and patient advocacy groups to gather insights and support product adoption.
- Sales Enablement: Develop training materials and sales tools to equip the sales team with the necessary knowledge and resources to effectively promote the product.
- Performance Monitoring: Establish key performance indicators (KPIs) to track product performance post-launch and implement strategies for continuous improvement.
- P&L Management: Oversee the product budget, ensuring effective allocation of resources to maximize ROI.
Requirements & Capabilities
- Education : Bachelor’s degree in Life Sciences, pharmacy, Business Administration, or a related field; MBA or advanced degree preferred.
- Experience : Minimum of 5 years of product management experience in the pharmaceutical industry, with a focus on cardiology, specialty, or rare diseases.
- New Product Launch : Proven experience in successfully launching new products in the pharmaceutical or biotechnology sectors, with a strong understanding of the launch process and lifecycle management.
- Innovative Marketing Development : Demonstrated ability to develop and execute innovative marketing solutions that resonate with healthcare professionals and patients.
- Patient-Centric Mindset : Strong commitment to understanding and addressing patient needs, ensuring that all strategies and initiatives prioritize patient outcomes and experiences.
- Proactive Listening : Ability to actively listen to both internal and external stakeholders to generate solutions by gathering insights.
- Effective Communication : Proven ability to communicate effectively with regional and global teams, ensuring alignment and collaboration across diverse stakeholders.
- Situational Leadership : Demonstrated capability to adapt leadership style to various situations and team dynamics, fostering collaboration and driving results.
- Sales Experience : Previous experience in sales or a strong understanding of sales processes is a plus, enhancing the ability to align product strategies with market needs.
- Quick learner and adaptor : Good capability of adopting changing environment and leaning new knowledges. Excellent analytical, strategic thinking, and problem-solving skills.
- Fluency in English : Excellent command of the English language, both written and spoken, is required.
- Entrepreneurial Spirit : A proactive and innovative mindset, demonstrating the ability to identify opportunities, take initiative, and drive projects forward in a dynamic environment.
Current Contingent Workers apply
*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.
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MSD Business Development Manager Taiwan, Taipei
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Job Description
esponsibilities:
Conducting market analysis and evaluating potential business opportunities: This involves studying market trends, competitive landscape, and customer demands to identify new prospects for partnerships & collaborations.
Establishing and nurturing strategic partnerships: Building relationships with key stakeholders such as healthcare providers, corporations, agencies, and other industries. The aim is to promote disease awareness, education, consultation, prevention, and treatment.
Developing and implementing business development strategies: Creating and executing strategies to expand the company's presence in disease prevention. This may include designing marketing campaigns, organizing educational events, or utilizing digital platforms to raise awareness about preventive measures.
Collaborating with cross-functional teams: Working closely with internal departments like marketing, sales, research and development, and regulatory affairs to align business development initiatives with organizational objectives. This collaboration ensures the integration of disease prevention efforts across the company's operations.
Monitoring industry trends and regulations: Staying up-to-date with the latest trends, regulations, and policies related to disease prevention. This helps in adapting strategies, ensuring regulatory compliance, and seizing emerging opportunities.
Assessing and monitoring the effectiveness of initiatives.
Participating in strategy development workshops to co-create strategies with the Franchise Lead and Cross-Functional Team (CFT).
Education
Bachelor’s Degree in Business, Marketing or related field
Agile knowledge/ certification is an advantage.
Key requirements / skills / leadership:
More than 4 years of experience on the medical industries or similar roles.
Excellent communication and negotiation skills: The capability to effectively communicate and present ideas, build relationships, and negotiate with potential partners or stakeholders.
Business acumen: A solid understanding of the pharmaceutical industry, market dynamics, and competitive landscape to effectively identify potential business opportunities and make informed decisions.
Relationship building and networking: The aptitude to establish and maintain strong partnerships with key stakeholders, including healthcare providers, corporate entities, and industry professionals.
Results-oriented mindset: A focus on achieving measurable results and meeting business objectives, with the ability to adapt strategies and approaches as needed.
Cross-functional collaboration: The capacity to collaborate effectively with internal teams, such as marketing, sales, research and development, and regulatory affairs, to align business development initiatives with broader organizational goals.
Flexibility and adaptability: The ability to navigate in a dynamic and rapidly evolving industry, adapting to changing market conditions and emerging trends.
Strong leadership and project management skills: The capability to lead and manage projects, oversee timelines, and coordinate cross-functional teams to ensure successful execution of business development initiatives.
Knowledge of regulations and compliance: Understanding of pharmaceutical regulations and compliance requirements to ensure adherence to legal and ethical standards.
What we look for
Current Contingent Workers apply
*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.
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MSD Associate Regulatory Affairs Manager AH Taiwan, Taipei
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Job Description
Job Overview
Under local regulatory requirements and responsible for all new product registration including new claims and licenses extension/renewal, to support business growth and business continuity, in compliance with local laws, regulations, guidelines and the company's policies & SOPs
Primary Accountabilities/Responsibilities
1. Under the general direction of supervisor, independently perform product registration including new product licensing and maintenance of existing product registration and renewals.
2. Compile registration dossier and prepare other regulatory documents (e.g., local package inserts, packaging components) and ensure timely regulatory submission under internal review and approval.
4. Support the progress of the registration projects by coordinating with the company’s internal departments (e.g. IRIS, Alexx, RTT, Reliance..etc)
5. Support the sampling process per commercial batches and work with Zuellig Pharma for tender operation.
6. Communicate and build relationship with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
7. Input and properly maintain all regulatory and legal documentation.
8. Collect internal and external regulatory and competitive information and report to supervisor.
9. Establish and maintain general understanding and knowledge of regulatory requirements, regulatory SOPs and other functional systems.
10. Assist in Quality affairs projects and procedures that are related to regulatory affairs.
11. Assist in any other regulatory tasks as assigned.
12. Coordinate the execution of local development and/or post marketing studies when applied.
Qualifications, Skills & Knowledge
- Prefer bachelor degree in science or animal science.
- At least 3-5 years’ experience in Veterinary Medicine/Pharmaceutical Company regulatory affairs.
- Sound Knowledge of Taiwan regulatory processes and requirements.
- Good communication skills in English
- Excellent interpersonal skills to handle sensitive and confidential information/situations and able to network effectively across groups and levels.
- Able to work independently
- Able to work under pressure and compliance with deadlines.
Other Information
Able to travel to meet business commitments where required.
Current Contingent Workers apply
*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.
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MSD Clinical Research Associate Taiwan, Taipei
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Job Description
Clinical Research Associate (CRA)
The role is accountable for performance and compliance for assigned protocols and sites in a country.
adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites.
Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased.
o Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.
• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
CORE Competency Expectations:
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
Behavioral Competency Expectations:
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
• Demonstrated high level of monitoring skill with independent professional judgement.
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Works with high quality and compliance mind-set.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
Experience and Educational Requirements:
- Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
- Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO
Current Contingent Workers apply
*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.
These jobs might be a good fit
Job Description
Role & Responsibilities
- Strategic Planning: Develop and execute the product launch strategy, including market analysis, positioning, and competitive landscape assessment.
- Cross-Functional Leadership: Collaborate with regulatory, market access, policy shaping, supply chain, sales, and medical affairs teams to ensure alignment and successful execution of the product strategy.
- Innovative Marketing Solutions: Design and implement innovative marketing strategies and campaigns tailored to the unique needs of the cardiology and rare disease markets to fulfill patients/HCPs’ needs.
- Stakeholder Engagement: Build strong relationships with key opinion leaders, healthcare professionals, and patient advocacy groups to gather insights and support product adoption.
- Sales Enablement: Develop training materials and sales tools to equip the sales team with the necessary knowledge and resources to effectively promote the product.
- Performance Monitoring: Establish key performance indicators (KPIs) to track product performance post-launch and implement strategies for continuous improvement.
- P&L Management: Oversee the product budget, ensuring effective allocation of resources to maximize ROI.
Requirements & Capabilities
- Education : Bachelor’s degree in Life Sciences, pharmacy, Business Administration, or a related field; MBA or advanced degree preferred.
- Experience : Minimum of 5 years of product management experience in the pharmaceutical industry, with a focus on cardiology, specialty, or rare diseases.
- New Product Launch : Proven experience in successfully launching new products in the pharmaceutical or biotechnology sectors, with a strong understanding of the launch process and lifecycle management.
- Innovative Marketing Development : Demonstrated ability to develop and execute innovative marketing solutions that resonate with healthcare professionals and patients.
- Patient-Centric Mindset : Strong commitment to understanding and addressing patient needs, ensuring that all strategies and initiatives prioritize patient outcomes and experiences.
- Proactive Listening : Ability to actively listen to both internal and external stakeholders to generate solutions by gathering insights.
- Effective Communication : Proven ability to communicate effectively with regional and global teams, ensuring alignment and collaboration across diverse stakeholders.
- Situational Leadership : Demonstrated capability to adapt leadership style to various situations and team dynamics, fostering collaboration and driving results.
- Sales Experience : Previous experience in sales or a strong understanding of sales processes is a plus, enhancing the ability to align product strategies with market needs.
- Quick learner and adaptor : Good capability of adopting changing environment and leaning new knowledges. Excellent analytical, strategic thinking, and problem-solving skills.
- Fluency in English : Excellent command of the English language, both written and spoken, is required.
- Entrepreneurial Spirit : A proactive and innovative mindset, demonstrating the ability to identify opportunities, take initiative, and drive projects forward in a dynamic environment.
Current Contingent Workers apply
*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.
These jobs might be a good fit
