Total 6 job vacancies by 3368 Merck Sharp & Dohme (Malaysia) Sdn. Bhd.

Job Description

• Join a Global Innovative Pharmaceutical Company

• Supportive and flexible team culture

• Great opportunity for Personal and Professional development
   

Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.

The Medical Advisor holds primary responsibility within the country for the development and execution of the Medical Affairs Plans for his/her assigned assets. The Medical Advisor is a valued co-strategist within cross-functional country teams, serving as a key liaison between internal and external stakeholders. In addition to facilitating peer-to-peer medical exchanges and engaging with scientific leaders and key decision makers to advance therapeutic and patient care knowledge, the Medical Advisor synthesizes actionable insights to inform portfolio strategies and lifecycle management. They translate global medical priorities and consolidated insights into localized strategies, driving initiatives such as real-world data generation, scientific communication, and educational programs aimed at enhancing patient outcomes and access to healthcare.  The Medical Advisor may have opportunities to manage multiple countries based on company strategies.

WHAT YOU WILL DO:

 Asset Management & Business Leadership

• Being product and disease state experts to contribute to the development and execution of medical strategy through the Medical Affairs Plans.

• Defining and maintaining a roster of Scientific Leaders (SLs) and Key Decision Makers (KDMs) in their therapeutic area and interacting with identified SLs and healthcare administrators (KDMs) by exchanging balanced medical / scientific information.

• Consolidate actionable medical insights from the country on scientific gaps, ideas and other topics gathered from Scientific exchange to inform areas of interest, clinical trial programs, development programs and company TA strategy.

• Adapt the Global Medical Goals and Strategies into the country’s context, to support/lead initiatives in local real-world data generation, facilitate scientific communication, educational programs, and other tactics and solutions to improve patient outcomes and enhance access in the country.

• Alert investigators to Company program for Investigator Initiated Study Proposals and to the process for submitting investigator designed proposals for review and approval; encourage and facilitate research publication of studies supported by the company, in strict compliance with global/local guidance.

• Work with GCTO to identify potential investigators for Phase 1, 2 and 3 clinical trials.

• Support execution of and quickly adapt tactical plan to business realities in country.

• Act with ethics & integrity; provide non-promotional, balanced, reliable, and scientific information, follow strictly company standards and local regulations.

• Performing all company business in accordance with company policies and procedures and country regulations

Scientific & Technical Leadership

• The Medical Advisor is responsible for ensuring that they are fully versed in the therapeutic area and up-to-date on: all major studies, both ongoing and completed; product information on company and other companies’ relevant therapies; clinical data and relevant pipeline data to provide the most accurate data to SLs, KDMs and the healthcare community, in a balanced way, to improve patient care.

• Build trust with external scientific community via peer-to-peer scientific exchange, research and educational collaborations, interactions with scientific societies and health organizations, publications, or others.

• Providing on-label medical insights and training to internal colleagues, including information on competitor products, as well as disease states relevant to their therapeutic area.

• Develop and execute country medical educational programs and symposia.

• Lead country advisory boards and group input forums to inform company strategy.

• Communicate both scientific and business needs credibly, appropriately, and effectively across a variety of internal and external stakeholders at all levels.

• Infuse country’s scientific and healthcare environment perspective into Regional Medical Affairs Team.

• Support, collaborate and lead resolution of Regulatory, Reputational (i.e. Public Relations), Compliance and other Asset issues management

• Support and collaborate in the successful management of asset safety or quality issues, i.e. contribute content and strategy in regulatory responses and interactions, risk management planning and implementation
   

Medical Information

• Respond to unsolicited requests for medical, scientific, pipeline, organization product information from SLs or KDMs utilizing appropriate approved scientific, and review/approval of local response documents.

What should you have:

• MD, PhD, PharmD or Pharmacist degree is required;

• 2-3 years in-field customer facing role and experience in the pharmaceutical industry is desired.

• Knowledge of local pharmaceutical industry guidelines, regulatory/reimbursement framework, and clinical research guidelines.

• Strategic thinking, specifically related to asset value proposition, and clinical and value evidence.

• Developing a network of scientific leaders and successful interactions with other key stakeholders (public groups, government officials, medical professional organizations) in therapy areas.

• Excellent interpersonal, analytical, communication (written as well as oral) and results oriented project management skills.

• Strong prioritization skills and ability to understand how decisions fit into the broader context of corporate strategies.

• In a matrix environment, able to effectively collaborate across functions.

• (Preferred) Network of medical, clinical contacts in Product/
  Therapeutic area.

Who we are:

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for  life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
 

 What we look for

 Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Senior Product Specialist - Penang

• Opportunity to be a part of Direct Sales GHH organization in Malaysia!

• Based in Malaysia the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company

• Join the premier biopharmaceutical company that has been in Malaysia for more than 25 years and in AP for over 60 years.

Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities

WHAT YOU WILL DO

Overall Job Purpose

• Detail, promote and sell our company’s products to the private or government healthcare professionals. The primary focus of activities is to drive business for products through building relationship with key stakeholders within the account.

• Achieve maximal sales and market share through personal promotion that is targeted and tailored for customers that benefit patients and adheres to ethical standards. Build and execute account management plans for top accounts. Ensure timely execution of planned activities.

• 100% compliant with internal medical, legal & compliance processes

Key Responsibilities (include % of time breakdown)

Strategic Sales Objectives & Sales Expertise (50%)

• To achieve strategic objectives as required by the franchise (e.g. market growth, sales growth, growth of accounts, formulary listings, new product market priming)

• Demonstrate high level of sales expertise and relationship management (through product & TA knowledge; selling skills, product presentation skills & managing customers)

• Be accountable for sales, activities and compliance within the assigned territory

Territory & Account Management (50%)

• Proactively plan and optimize overall sales results performance through effective territory management

• Demonstrate ability to resolve problems in timely manner, escalate issues early

• Effective planning & execution of marketing/promotional activities according to plan (eg Focus Group Meeting, Lunch & Learn, Scientific leader engagement program & digital programs execution)

• Ensure timely submission and approval of documentations & reports for activities

• Build and execute account plans for key accounts, through in-depth understanding of customers (profile/behavior/influence network/needs etc.)

Education Level
 

• Degree in Pharmacy/ Biomedical Science/ Microbiology/Science
 

Experience
 

• Minimum 3-5 years pharmaceutical sales experience in Pharmaceutical industry- Multisector

• Experience in Vaccines is an added advantage

• Strong presentation skills, positive attitude and strong sales achievement

• Strong customer focus and proven relationship building skills

• Good track record in sales, with a history of achieving results

• No experience but with a good business acumen can be considered
 

Leadership competencies
 

• Focus on customer & patients

• Drive results, rapid & disciplined decision making

• Demonstrates Ethics and Integrity

• Displays courage & candor

• Fosters collaboration
 

Functional Competencies
 

• Self-driven and proactive to manage the dynamics of the cross functional team, including planning & problem solving

• Uses relationship building skills (e.g. opening, need-based selling, intimate customer understanding) to effectively influence the target audiences

• Develops clear call objectives based to obtain the desired behavioral outcome

• Identifies drivers and barriers (opportunities and objections / obstacles) and applies objection handling techniques to lead the discussion process to a positive outcome

• Identifies buying signals and makes a direct and compelling request / recommendation based on the desired behavioral outcome (close the sale)

• Presents self professionally and delivers messages confidently

• Effectively executes promotional programs and brand / franchise messages to the targeted segment

• Utilizes effective time management (e.g. route planning) to maximize reach and access to customers

• Routinely seeks customer feedback and provides timely and useful communication to internal and external customers

• Captures and utilizes ongoing customer information and competitor intelligence using available technology

• Tracks, verifies and optimizes reach, frequency and tactical promotion objectives for identified customer groups over the short and long term

• Routinely follows up and finds solutions to address objections / issues

• Develops an integrated sales/account plan based on marketing strategy, competitor assessment, customer understanding, business opportunity and key tracking metrics

• Generates target list from agreed customer segments with prioritization based on individual potential and influence

• Applies internal data and competitor/ market information (e.g. IMS data) into plan development

• Refines plan when appropriate (e.g. selling activities) based on customer feedback and optimal return

• Achieves synergy with the planning of other functional groups (e.g. medical, public affairs) in interacting with customers

• Utilizes available technologies in planning activities

• Allocates agreed resources to achieve business objective and desired ROI

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

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

Secondary Language(s) Job Description:

language: English, Bahasa Melayu and Chinese

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Clinical Research Associate (CRA)
 

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• We were awarded ‘Sponsor of the Year’ in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!
• We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future!
• Join the premier biopharmaceutical company that has been in the business for more than 125 years

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and 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:

• Data generated at site are complete, accurate and unbiased.
• 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 internally 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 strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

Extent of Travel:

• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
• Current driver’s license preferred (Must have in certain countries).

Qualifications, Skills & Experience

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.

Behavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
• 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 Requirements:

Required:

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

Preferred:

• B.A./B.S. with strong emphasis in science and/or biology.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Senior Product Specialist

• 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.

Overall Purpose

• Detail, promote and sell our company’s products to the private or government healthcare professionals. The primary focus of activities is to drive business for products through building relationship with key stakeholders within the account.
• Achieve maximal sales and market share through personal promotion that is targeted and tailored for customers that benefits patients and adheres to ethical standards. Build and execute account management plans for top accounts. Ensure timely execution of planned activities.
• 100% compliant with internal medical, legal & compliance processes

WHAT YOU WILL DO

Responsibilities include, but are not limited to: 

Strategic Sales Objectives & Sales Expertise (50%)

• To achieve strategic objectives as required by the franchise (e.g. market growth, sales growth, growth of accounts, formulary listings, new product market priming)
• Demonstrate high level of sales expertise and relationship management (through product & TA knowledge; selling skills, product presentation skills & managing customers)
• Be accountable for sales, activities and compliance within the assigned territory

Territory & Account Management (50%)

• Proactively plan and optimize overall sales results performance through effective territory management
• Demonstrate ability to resolve problems in timely manner, escalate issues early
• Effective planning & execution of marketing/promotional activities according to plan (eg Focus Group Meeting, Lunch & Learn, Scientific leader engagement program & digital programs execution)
• Ensure timely submission and approval of documentations & reports for activities
• Build and execute account plans for key accounts, through in-depth understanding of customers (profile/behavior/influence network/needs etc.)

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Degree in Pharmacy/ Biomedical Science/ Arts/ Business
• Minimum 5 years pharmaceutical sales experience in Pharmaceutical industry
• Experience in Oncology is an added advantage
• Strong presentation skills, positive attitude and strong sales achievement
• Strong customer focus and proven relationship building skills
• Good track record in sales, with a history of achieving results
• Experience in handling projects from end to end

What we look for…

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us — and start making your impact today.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Specialist, 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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Role Summary

Responsible to support the day-to-day operations of Asia Pacific Labeling & Artwork Hub. Perform tasks as requested by the participating countries, to deliver labelling and artwork tasks in accordance with our company’s labelling and artwork guidelines, including but not limited to:

•    Evaluation of labeling activities

•    Coordination with Country Regulatory Affairs’ points of contact

•    Preparation of labeling content, solicit internal review & approval, as appropriate

•    Creation of artwork to support regulatory submissions and market implementation

•    Ensure compliance at all times

Key Responsibilities:

•    Product Label Management

•     Ensure that product labelings are updated in accordance with respective country and corporate guidelines. 
•     Ensure proper maintenance of tools and systems used in the creation and maintenance of labeling materials and artworks e.g., REDS, BWEL, Artwork Management System as well as associated databases and team sites. 
•     Ensure prompt availability of labels and artworks and liaises with departments such as Business Development, Medical, Marketing, Training, PV and external partners to ensure compliance with established regulations. 
•     Ensure communications with business partners and the archival of such communications meet corporate guidelines. 
•     Support participating countries to ensure prompt implementation of labeling changes (safety and non-safety) for marketed products and liaise with various packaging sites, artwork centers and internal departments, for compliance with established regulations and to prevent stockout and minimize discards. 
•     Maintain databases and team sites by ensuring updated and accurate information are uploaded. 

•    Compliance 

•     Drive compliance according to participating countries’ set procedures and standards by ensuring required metrics are met.
•     Ensure efficient execution of strategic regulatory and implementation plans to achieve the desired results and avoid stock-outs. 
•     Ensure deliverables are achieved as planned to quality and timeliness targets 

•    Individual must possess 

•     A quality mindset 
•     Strong orientation to details 
•     Proactive 
•     Flexible 
•     Results-oriented 
•     With very good communication skills

Education Minimum Requirements:

• Bachelor of Life Science

Required Experience and Skills:

• At least three (3) years of experience in multinational companies with knowledge on drug product registration and lifecycle maintenance
• Excellent English oral and written communication skills and presentation skills
• Planning and Project Management o Plans & coordinates works/projects and manages planning processes, techniques and practices to track progress and achieve desired goals.
• Communication o The ability to communicate effectively across a range of written and oral situations, related particularly to the creation of understanding around complex or contentious issues.
• Technical Expertise o Understands, applies, performs tasks and improves technical knowledge and skills related to area of expertise to achieve outcomes
• o    Knowledge of drug product manufacturing & quality assurance
• o    Strong background of prevailing regulatory guidelines and requirements
• o    Knowledge of participating countries labeling and artwork regulations and process
• o    Literacy in computer operation, particularly with Microsoft applications
• Act with Courage and Candor: Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
• Demonstrate Ethics & Integrity: Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
• Drive Results: Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
• Foster Collaboration: Actively listen and seek to understand differing perspectives; work together to achieve the common goals of our company.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):