Total 27 Trade Tariff Manager job vacancies in Malaysia MYS

Emerging Markets Partner Business Manager

Description -

What an Emerging Markets Partner Business Manager does at HP:

• Serves as the expert to the partner for complex information regarding product, services, and software transitions, promotions, and configurations.
• Educates and updates partners on new HP technologies or solutions. May be brought in by partners to sell HP brand to end customers.
• Establishes and maintains account plans to promote sales growth.
• Achieves assigned quota for HP products, services, and software.
• Transactional and relationship selling working within a team of selling professionals.
• Creates, fills-in and manages HP funnel for deals with partners and transforms potential leads into joint sales activities.
• Establishes relationship with partner at all organization levels including senior executives.
• Ensures partners are compliant with legal and SBC practices.
• May drive SOW growth with distributors who are managing small partners on behalf of HP.
• May recruit and develop business relationship with new partners.

Individuals who do well in this role at HP, usually possess:

• University or Bachelor's degree preferred.
• Typically 5-8 years of selling experience at end-user account or partner level.
• Solid experience in selling to partners in a complex environment.
• Solid understanding of the IT industry, competing vendors, and the channel. Dimensions include competitive positioning.
• Solid understanding of HP's organization & operations, including key business rules, and alignment with HP go-to-market strategies, partner segmentation, key programs & initiatives, structure.
• Solid understanding of many of HP's products, software, and services. Able to communicate the strengths of HP's offerings, and overcome objections.
• Effectively sells HP offerings by building strategic relationships with partner decision makers; and promoting HP programs and offerings.
• Develops account plans with partner to grow HP's share of the business.
• Partners effectively with others in the account to ensure coordinated efficient account management.
• Ability to motivate partner's sales force.
• Solid understanding of pipeline management discipline and ability to explain benefits to partners.

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.
 

#Li-Post

Job -

Sales

Schedule -

Full time

Shift -

No Shift premium (Malaysia)

Travel -

50%

Relocation -

Equal Opportunity Employer (EEO) - 

HP, Inc. provides equal employment opportunity to all employees and prospective employees, without regard to race, color, religion, sex, national origin, ancestry, citizenship, sexual orientation, age, disability, or status as a protected veteran, marital status, familial status, physical or mental disability, medical condition, pregnancy, genetic predisposition or carrier status, uniformed service status, political affiliation or any other characteristic protected by applicable national, federal, state, and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

If you’d like more information about HP’s EEO Policy or your EEO rights as an applicant under the law, please click here: Equal Employment Opportunity is the Law Equal Employment Opportunity is the Law – Supplement

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. 

We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. 

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Finance Manager to be based in Perai, Penang.

Here is a glimpse of what you'll do:       

• Recommends modifications to existing site programs.
• Prepares reports that summarize company business activity and financial position.
• Approves new customer requests.
• Establishes or recommends proper accounting treatment or methods.
• Provides Fiduciary responsibility with regards to disbursement of all company funds.
• Furnishes management with timely reviews of organization's financial status and progress in its various programs and activities.
• Directs determination of depreciation rates to apply to capital assets.
• Advises management on desirable operational adjustments due to tax code revisions.
• Arranges for audits of company's accounts.
• Prepares reports required by regulatory agencies.
• Establishes relations with banks and other financial institutions.
• May specialize in managing a subsection of the Finance function such as Accounts Payable, Accounts Receivable, Cost Accounting, General Ledger, Payroll, Shared Services or other Accounting-related area.
• Implement appropriate HR Strategies and actions to recruit and retain a qualified and motivated workforce.

  The experience we’re looking to add to our team:

 

• Typically requires a bachelor’s degree in finance, Accounting or related field or equivalent experience and training.
• Typically requires a minimum of 8 years of related experience.
• Masters of Business Administration (MBA) or a Master of Science and Accounting (MSA) preferred.

KR40

Job Category

Finance

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).

Services Channel Business Development Manager - Malaysia

Description -

We are looking for a Channel Business Development Manager to join our team to drive a transformational change in the reseller channel. Our aim is to develop partners so that they can provide a consolidated workplace experience for their customers.

The candidate, who has both strong sales and business management skills, with experience in the services and contractual space, would be based in a global organization, but responsible for a set of partners / countries. The role includes understanding, driving and achieving / over-achieving sales targets and, as part of the country sales organizations, the execution of centrally designed initiatives, utilizing global tools to promote local channel business, as well as analyzing market environment and challenges, and consolidating local requests and help needed. Responsibility also includes establishing the right business governance with the partner landscape, managing the current channel activities, and recruiting new partners.

Scope of the role is HP’s Personal Computing and Office Printing Services and Solutions portfolio across product lifecycle services, managed print services and PC & Print Software, in one word: HP Workforce Solutions portfolio.

This role is ideal for people who want to be part of the emerging HP business area for the future and drive its growth and development.

Partner enablers to help grow sales and delivery of HP Services (PC and Print) (including value proposition, program, tools, dashboards, incentives)

What a Lifecycle Services Channel BDM – Malaysia does at HP:

• Partner enablement: value proposition, collaterals, trainings

• Partner selection, segmentation, adoption, certification

• Services channel programs deployment

• Partner Services joint business plan for top partners

• PBM education on channel tools, programs, growth initiatives

• Business dashboards & analysis

• Linkage to technical support resources

• Limited to no involvement in end-user sales or partner account management

Key performance metrics 

• Services p-rate

• Sell-thru, services mix

• Growth initiatives performance

• Number of partners selling Services

• Channel program partner participation

• Partner share of business

• Engagement with other teams 

• Day to day Partner engagement together with Market Channel Sales team

• Feedback on products, pricing, value proposition, sales enablement, and growth initiatives to Global channel Workforce Solutions and GBU

• 4P planning: channel incentives development with Services Categories

Individuals who do well in this role at HP, usually possess:

• Services sales background

• Partner management experience

• Good mix of analytical and action-oriented mindset

• Good communication skills within Market and on global level

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.

#Li-Post

Job -

Sales

Schedule -

Full time

Shift -

No Shift premium (Malaysia)

Travel -

Relocation -

Equal Opportunity Employer (EEO) - 

HP, Inc. provides equal employment opportunity to all employees and prospective employees, without regard to race, color, religion, sex, national origin, ancestry, citizenship, sexual orientation, age, disability, or status as a protected veteran, marital status, familial status, physical or mental disability, medical condition, pregnancy, genetic predisposition or carrier status, uniformed service status, political affiliation or any other characteristic protected by applicable national, federal, state, and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

If you’d like more information about HP’s EEO Policy or your EEO rights as an applicant under the law, please click here: Equal Employment Opportunity is the Law Equal Employment Opportunity is the Law – Supplement

Key Responsibilities

1. Develops and maintains customer relationship with all relevant individuals in his/her district at all times, at all levels. Performs regular customer visits.
2. Manages, coaches and directs all customer engineers in his/her district. Responsible for salary planning, career planning, corrective actions where necessary, establishes objectives and performance appraisals. Gives formal updates to all employees. Business, new hires, new products. Can invite any guest speaker.
3. Initiates reports necessary for the business. Be the prime interface with the Product Divisions: tech support, training, spares, reliability.
4. Monitors the CSD Award Program with quarterly results (election, announcements). Monitors the “mentor” program so that all new engineers have a defined mentor.
5. Executes escalation procedure.
6. Responsible for account planning with District Sales Engineer. Provides support plan for system sales to CSD Management, Sales, Field Engineering. Responsible for financial forecast for his/her district. Responsible for cost efficiency with the district. Measured by the financial result.
7. Responsible for system installation; planning, reporting and execution, pre-facility meeting, start-up meeting, process support identification.
8. Manages RMA procedure. Measurement of the engineers on their effectiveness. Manages accuracy, understanding and update of Customer Engineer hours tracking. Personal cross check and signature, measures customer engineers, takes corrective action with customer engineers. 

Functional Knowledge

• Works on issues where analysis of situation or data requires review of relevant factors

Business Expertise

• Receives assignments in the form of objectives with goals and the process by which to meet goals. Recommends changes to unit or sub-unit policies. Management reviews work to measure meeting of objectives

Leadership

• Provides direction to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees

Problem Solving

• Exercises judgment within defined procedures and policies to determine appropriate action.

Impact

• Erroneous decisions or failure to achieve results will cause delays in schedules.

Interpersonal Skills

• Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

Position requires understanding of Applied Materials global Standards of Business Conduct and compliance with these standards at all times. This includes demonstrating the highest level of ethical conduct reflecting Applied Materials' core values.

Qualifications

Education:

Bachelor's Degree

Skills:

Certifications:

Languages:

Years of Experience:

4 - 7 Years

Work Experience:

Additional Information

Time Type:

Full time

Employee Type:

Assignee / Regular

Travel:

Yes, 25% of the Time

Relocation Eligible:

Yes

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. 

     

JOB DESCRIPTION:

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Category Management

     

DIVISION:

GPS Global Purchasing Services

        

LOCATION:

Malaysia > Selangor : Imazium, No. 8, Jalan SS 21/37

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

     

     

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. 

We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. 

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add an Automation Technical Project Manager located in Batu Kawan, Penang.

What a typical day looks like:

• Search for potential customer or potential project
• Specific customer management and communication.
• Lead the planning and implementation of an automation project
• Facilitate the definition of project scope, goals, and deliverables
• Define project task and resource requirements
• Mange project resource allocation
• Plan and control project timelines
• Estimate project budget, and control the cost within the budget
• Collaboration with other functions to compliancy the law and rules (Information Security, Finance, EHS, ESD, CE, UL, etc.)

The experience we’re looking to add to our team:

• Bachelor's Degree in Automation Engineering, Computer Science, Software-Engineering, Electrical Engineering or Mechanical Engineering
• Has manufacturing process or automation development background is prior.
• A similar TPM role with a minimum of 5 years of experience in development & deployment for automation project or automatic product
• Proficiency in engineering software is a plus (C++, LabView, PLC, SolidWorks, Robot, etc.)
• Project planning & schedule control & quality control & project management
• Estimate project cost, and implement project to control the cost within the budget
• System verification in whole development process with good abilities of troubleshooting & high-quality awareness
• Data analysis and reporting.
• Know DFMEA, PFMEA, DOE, CPK, GR&R, related assistance tools be plus
• Familiar related standard & system, like ISO9001, TS16949, EMS IPC-3 be plus

What you’ll receive for the great work you provide:

• Medical benefits, dental, vision
• Life Insurance
• Paid Time Off
• Performance Bonus

NB87

SG70

Job Category

Production Engineering

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).

Who we are

Build your best future with the Johnson Controls team.

As a global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. Join a winning team that enables you to build your best future! Our teams are uniquely positioned to support a multitude of industries across the globe. You will have the opportunity to develop yourself through meaningful work projects and learning opportunities. We strive to provide our employees with an experience, focused on supporting their physical, financial, and emotional wellbeing. Become a member of the Johnson Controls family and thrive in an empowering company culture where your voice and ideas will be heard – your next great opportunity is just a few clicks away!

What you will do:

Responsible in achieving company objectives by assisting Applied Sales Engineer to provide air-conditioning solutions to customers.

How you will do it:

• Understand customers’ requirements for air conditioning equipment and solutions.

• Provide heat load calculations and estimation to customers base on standards, requirement and application.

• Prepare air Conditioning equipment selection, costing and budgetary to customers base on the required specifications.

• Conduct technical and product presentations to consultants & end users virtually and physically.

• Work with Applied Sales team & to seek potential customers in local market and maintain good relationships with the stakeholders of the projects.

• Prepare weekly sales report & project tracking record to analyze and track the status of the projects.

• Collect, gather and analyzes competitive comparisons, pricing trends, and market analysis of the competitor landscape.

• Provide feedback or voice of the customers to the company on market requirements and regulations.

• Integrate business strategy and develop specific objectives for Business within Singapore and extend to SEA region. Work with leadership team to define the optimal engagement model for an early engagement and sales opportunity and engage with Heads of sales wherever appropriate to support the model.
• Lead the development of client relationships with owners, developers, consultants and contractors to improve JCI positioning and ultimately command customer preference.
• Create a healthy mid-long term pipeline of projects for HVAC solutions through spec-in activities and key accounts/vertical development efforts.
• Study and analyze competitive environment to prepare monthly updates to Sales Leaders in SEA and in countries with information relevant to their markets.
• Assess, develop and maintain updated market share data in each country with objectives to grow JCI market participation year over year.   
• Develop client-specific engagement and implementation proposals.

What we look for:

• 10+ years’ experience delivering consulting services, including team leadership and active involvement in selling professional services

• 5+ years’ operating in a pre-sales environment, shaping and scoping large and complex implementation projects

• 5+ years of enterprise-level project or program management experience

• Possess senior level relationship in the building technologies market to support Sales Team in their sales efforts

• Proven leader and developer of people working in diverse team environments.

• Demonstrated technical and/or functional aptitude, and ability to engage with architects/owners/consultants or SME into pre-sales activities.

• Extremely strong written and verbal communication skills, executive level presence and experience in working in a client advisory role

• Demonstrated ability to influence a group audience, facilitate solutioning and lead discussions such as implementation methodology, Road mapping, Enterprise Transformation strategy, and executive-level requirement gathering sessions

• Excellent analytical & problem solving skill

• Business acumen, good interpersonal and communication skills

• Able to work independently with minimum supervision.

What we offer:

• Competitive salary

• Paid vacation/holidays/sick time

• Comprehensive benefits package

• On the job/cross training opportunities

• Encouraging and collaborative team environment

• Dedication to safety through our Zero Harm policy

#LI-GO1

#LI-Onsite

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. 

We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. 

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add an Automation Technical Project Manager located in Batu Kawan, Penang.

What a typical day looks like:

• Search for potential customer or potential project
• Specific customer management and communication.
• Lead the planning and implementation of an automation project
• Facilitate the definition of project scope, goals, and deliverables
• Define project task and resource requirements
• Mange project resource allocation
• Plan and control project timelines
• Estimate project budget, and control the cost within the budget
• Collaboration with other functions to compliancy the law and rules (Information Security, Finance, EHS, ESD, CE, UL, etc.)

The experience we’re looking to add to our team:

• Bachelor's Degree in Automation Engineering, Computer Science, Software-Engineering, Electrical Engineering or Mechanical Engineering
• Has manufacturing process or automation development background is prior.
• A similar TPM role with a minimum of 5 years of experience in development & deployment for automation project or automatic product
• Proficiency in engineering software is a plus (C++, LabView, PLC, SolidWorks, Robot, etc.)
• Project planning & schedule control & quality control & project management
• Estimate project cost, and implement project to control the cost within the budget
• System verification in whole development process with good abilities of troubleshooting & high-quality awareness
• Data analysis and reporting.
• Know DFMEA, PFMEA, DOE, CPK, GR&R, related assistance tools be plus
• Familiar related standard & system, like ISO9001, TS16949, EMS IPC-3 be plus

What you’ll receive for the great work you provide:

• Medical benefits, dental, vision
• Life Insurance
• Paid Time Off
• Performance Bonus

NB87

Job Category

Production Engineering

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).

Job Description

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

• Minimum 4 years with specific to sales experiences. Veterinary Medicine or Animal Science background is preferable.
• Good in data analytic, strategic thinking, planning and execution.
• Ability to multitask, prioritize, and manage time efficiently
• Good interpersonal relationship skills
• Strong negotiation skills, with ability follow-through on client contracts
• Good leadership and coaching skills.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Regulatory Affairs Manager - Animal Health

• Opportunity to be a part of a global Regulatory Affairs – General organization in Malaysia!
• Based in Malaysia, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Malaysia for more than 25 years and in AP for over 60 years.

Primary Responsibilities

Regulatory

• Product registration

• Plan, manage and oversee RA activities within the coverage region

• Manage and oversee all product’s regulatory lifecycle process; submission; approval and maintenance activities (variation, renewal) in relation to the following national regulatory authorities as follows:

Malaysia

- Department of Veterinary Services (DVS) Putrajaya, Sabah & Sarawak, MoA

- National Pharmaceutical Regulatory Agency (NPRA), MoH

- Pharmaceutical Services Division (BPF), MoH

- Pesticides Board, MoA

Singapore

- Animal & Veterinary Services (AVS) / National Parks Board (NPARKS), MoA

Brunei

- Division of Livestock and Veterinary Service, MoA

- Department of Fisheries, MoA

• Act as Poison A (Wholesale) License holder
• Assess registration feasibility and acceptability of products for importation
• Registration timeline setting and communication to RA team as well as local and global cross-functional units
• Identify data needed, prepare and/or obtain data and review to ensure that they are effectively presented for the registration of product
• Interact with and present to national regulatory authorities on regulatory related new product submissions strategies and maintenance of current product portfolio, as applicable
• Manage positive networking relationship with national regulatory authorities as necessary
• Provide regulatory review of variation proposals, labeling and additional submission documents
• Assess regulatory of product variations on product lifecycle and communicate as necessary to line-management and cross functional teams
• Collaborate with global regulatory affairs functions to develop global regulatory submission and approval strategies
• Provide correspondence to national regulatory authority enquiry(s) for products responsible
• Provide regulatory advice and guidance to line-management and cross functional teams to ensure product submissions and importations meet regulatory requirements
• Review and verify packaging labels where applicable, revise labels by using PDF program per local regulatory authority requirement for registration and importation
• Develop SOPs and provide regulatory input to product life-cycle planning
• Manage secondary repackaging procedures in line with SOPs and regulatory requirements
• Maintain up-to-date legal and regulatory knowledge on the registration, import and sale of products.
• Oversee and develop a team of highly motivated, experienced and dedicated direct reports

Education Minimum Requirement:

• Graduates with Science related degree eg. Veterinary science / Animal science BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
   

Required Experience and Skills:

• 5-7 years in Regulatory Affairs of Animal Health industries
• Experienced in handling registration of veterinary biological products, dealing with Department of Veterinary Services (DVS).
• Veterinarian or Pharmacist are welcome

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

As a Local Trial Manager, you will be responsible for local management of a clinical trial in a country or countries, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations.

RESPONSIBILITIES

• Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. Accountable for study deliverables and drives key decisions within set country.

• Plan, manage, and maintain oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team.

• Support country-level operational planning and accountable for site selection within assigned country.

• Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.

• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country.

• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training.

• Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.

• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.

• Monitor the execution of the clinical study against timelines, deliverables, and budget for that country.

• Monitor and review country and study trends, review Monitoring Visit Reports.

• Identify and facilitate resolution of cross-functional study-specific issues.

• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.

• Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships.

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree in a healthcare or other scientific discipline

• Minimum 2-3 years’ local /regional trial project management experience

• Knowledge / expertise of regulatory environment, study start up process and associated timelines etc.

• Clinical trial processes and operations

• Extensive knowledge of ICH/GCP regulations and guidelines

#LI-Hybrid

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Job Description

Manager, Regulatory Affairs

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.

Key Responsibilities:

• Develop and implement regulatory strategy to accelerate products and indications pipeline
• Drive regulatory policy shaping initiatives with local regulatory agency, trade association and other external stakeholders.
• Ensure regulatory support through product life cycle including labelling, CMC and dossier modifications
• Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes
• Lead/participate in negotiations during regulatory approval processes for applications with the regulatory agencies
• Participate in inter-company organizations focusing on specific industry-related issues
• Keep abreast on all regulatory requirements (local, ASEAN, ICH, WHO), market, and industry developments
• Build long term effective relationships and keeps open communication with Regional / Global colleagues
• Monitor regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies
• Cooperate with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others
• Contribute with regulatory support during health authority site inspections
• Attend inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes
• Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements
• Participate in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations
• Serves as a local in-house CMC expert and able to provide a specialized perspective for product life-cycle management.

Education Minimum Requirement:

• Graduates with Pharmacy degree or graduates with Science related degree eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
• First class honours or high second upper degree
   

Required Experience and Skills:

• Registered pharmacist are encouraged to apply
• A minimum of 10 years of relevant pharmaceutical regulatory experience, preferably with MNC background, including experience in regulatory affairs policy shaping and CMC
• Ability to communicate well verbally and in writing to internal and external stakeholders is essential
• Detail oriented, meticulous and organized
• Has basic IT knowledge
• Able to work within targeted timelines
• Advanced project management skills
• Self-motivated and strong commitment to achieve desired results and right first time
• Team player

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

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Flexible Work Arrangements:

Hybrid

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