Current Openings at MSD

Position Overview - Basic Functions & Responsibility

The role reports to Associate Vice President – Quality and is part of Global pharmaceutical operations Packaging Quality leadership team. Implementation of and management of the quality system at the site in accordance with divisional and local requirements. Champion GMP activities at the site by fostering GMP awareness and conformance to the plant's GMP commitment. The role also oversees the quality and release activities for our company's directly imported products into SA and related GDP activities. 

• Management of Quality operations department by ensuring adequate staffing and training to undertake the responsibilities for Quality activities and ensuring adequate performance management.
• Ensure a Quality management system is in place in accordance with our company and local regulatory requirements.
• Ensure all materials and products are tested and released or rejected in accordance with Specifications including materials tested by external laboratories.
• Final approval for reports such as; Internal and external customer complaints; Manufacturing deviations; OOS or atypical analytical test results
• Play a key role in developing corrective actions and preventive actions and ensure they have been effectively implemented.
• In cases of significant deviations, initiate and conduct fact-finding activities and report to divisional recall committee where applicable, through responsible QA Business Head.
• Monitor site's abilities to recognize and correct system problems by evaluating the number and types of deviations generated.
• Ensure hold time stability program for intermediate products and stability program for finished products is in
• place as advised by divisional stability hub.
• Establish and approve local Standard Operating Procedures that impact product quality. Assure conformance to divisional Policies, Procedures and Guidelines.
• Ensure compliance with current Good Manufacturing Practices, Good Distribution Practices and quality policies in all site departments involved in packaging activities or those that support packaging and distribution activities.
• Review and approve where necessary validation and applicable qualification activities related to: Analytical methods; Laboratory and packaging equipment qualification; Computer and automated systems involved in testing, manufacturing, materials control; Equipment cleaning procedures; Utilities with product contact; Final approval on Quality / GMP related changes
• Champion cGMP at the plant by organising and chairing local Quality Council that fosters GMP awareness and commitment.
• Ensure and approve local GMP audit activities.
• Serve as primary contact for agency inspectors during regulatory inspections.
• Review of annual product reviews and use data to identify improvements required.
• Maintain oversight of external contactors and activities conducted at other sites by means of quality agreements and audits as applicable.
• Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact DIPOC.
• Ensure adherence to Quality agreements as related to CMOs activities performed by Midrand site
• Support site safety objectives and site portfolio. Promote with QO MPS lean thinking and continuously strive for improvement.
• Prepare annual department budgets and ensure that expenditure is within budget during the year.

Qualifications/ skills

• Degree in Pharmacy or related scientific discipline.
• Knowledge of GMP principles, GDP principles and South Africa GMP requirements (SAPHRA)
• Scientific based decision-making ability.
• Knowledge of QA and Laboratory processes.

Experience required

• At least 6-8 years’ experience leading QA or related pharmaceutical manufacturing functions.
• Knowledge of Computerized systems

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Job Description

EEMEA Employee Relations Partner creates value through trusted partnership, by finding solutions that consider the experience of our employees and the interests of our Company. This position is responsible for coaching and training leaders and HR Business Partners to create a Safe to Speak up culture, operating on a balanced, neutral perspective to support successful navigation through challenging moments, which will contribute to the positive reputation of our Company.

This position will be responsible for investigating cases that are channeled through Human Resources. Position’s responsibilities will include intake, case planning, interviews, data review, documentation, and making recommendations regarding corrective actions regarding remediation or & escalation.

Main non-limiting responsibilities:

• Manage, conduct, and complete and track investigations in EEMEA. Act as investigator or as a point of escalation for complex complaints including but not limited to those involving allegations of discrimination, harassment, hostile work environment, retaliation, and other potential violations of company policy and labor/employment law and serve as a point of handoff/escalation from internal partners.
• Provide thought leadership to business leaders and the HR organization, engaging internal and external partners and stakeholders to drive business initiatives to conclusion when needed.
• Promote a culture of Speak up that can generate psychological safety for employees by demonstrating that verified cases of misconduct will be acted upon and the belief that unethical behavior is not tolerated.
• Partner with Legal, Compliance and HR to ensure we have the appropriate processes, systems and tools to support the safe to speak up culture in EEMEA.
• Together with Compliance and Legal, reinforce Manager’s education in all these related matters. Train managers to encourage employees to speak out. Managers must visibly demonstrate actions taken for misconduct.
• Ensure managers are prepared to manage and escalate concerns by seeking transparency of messaging in verified cases of misconduct.
• Support HR Teams to build a culture of trust that permeates every level of the organization with a focus on the misconduct reporting process, so they feel more comfortable speaking up. Support HRBPs capabilities and education in Compliance. Draws insights and identifies opportunities from the day-to- day operation across populations at a site, country, and regional level. Provides quarterly ER Business Insights to EEMEA senior leadership.
• Ensure there are escalation paths for serious issues and send regular self-check reminders to help managers reinforce good behaviors.
• Partner with legal & compliance and the Office of Ethics to track cases, mitigate risk, minimize litigation, and propose action to continue reinforcing the safe to speak environment.
• Build transparency into systems and processes that support expression and provide a comfortable and conducive environment for reporting misconduct with the HR community.
• Understand local labor laws for correct application.
• Expand compliance risk registers and impact metrics for organizational risks and analyze data to continue provide improvement proposals, identifying areas where we have policy gaps, as well as influencing and advising on changes necessary to ensure local or regional policies are clear, relevant, an applicable.
• Demonstrate the expected behaviors beyond specific training, reinforcing more transparent investigation processes.
• Incorporate DE&I metrics along with tracking compliance metrics.

Qualifications & experience:

• Experience of conducting and managing investigations from intake to conclusion
• Familiarity with compliance guidelines and data protection legislation.
• Previous experience working with cross-functional teams (not mandatory).
• Proven ability to develop sustainable, cooperative professional relationships at all levels of the organization.
• Demonstrated ability to leverage technology and data to generate insights as a foundation for diagnosis, recommendations, and decisions.
• Preferably knowledge and experience with all aspects of compliance including laws, regulations, procedures, policies and standard operating procedures, and knowledge of the guidelines.
• Preferably change management experience and understanding
• Language: must be fluent in English. Arabic and French good knowledge would be considered a plus.

Education & Experience

• Bachelor's Degree required.
• Minimum 5 years work experience in related areas (HR, Compliance, Legal, Business Practices and related fields etc.)

Skills & Behaviors

• Impactful verbal and written communication, and interpersonal skills
• High ethical standards, being a role model of compliance and business integrity.
• Pronounced diplomacy with great negotiating, mediation, and coaching skills; strong cultural awareness and ability to instill a mindset of compliance among all areas and stakeholders of the organization.
• Collaboration: ability to achieve collective goals and coordinate effectively to achieve them.
• Solutions to complex problems, creating order and simplicity from complex problems.
• Work plan development: ability to identify, group and sequence the tasks necessary to achieve a given goal and assign deadlines and responsibilities.
• Time Management and Prioritization: ability to identify urgent and important activities, prioritize them appropriately, and choose the most efficient way to complete them.
• Highly skilled at having difficult conversations, able to coach and use the creative mindset to help people see a situation differently.

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Job Description

This role will be key to further develop the country capabilities in clinical research. Under the oversight of the country or cluster CRD the person will be responsible for the end to end performance of clinical trials in 1 or several TA, from feasibility to close out in 1 or several countries. The role should be responsible for 30 to 50 clinical trials and will ensure excellent study performance with strict adherence to local regulations, our Company's SOPs and ICH GCP.

The role is responsible for oversight of all the employees working in the TA, with line management for Clinical Research Managers (CRM) and functional oversight of other roles in studies.

As line manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles.

The role will work at country level with other local stakeholder like Medical, PV, regulatory and commercial to ensure alignment and development of the country capabilities and can represent the CRD of cluster in local management if required. CRD can delegate certain key tasks as needed.

Responsibilities include, but are not limited to:

• Will lead 1 or several therapeutic areas of the growing portfolio in South Africa and Africa
• Accountable for the successful execution, enrollment and quality of their clinical trial portfolio
• Accountable to ensure timelines and key milestones are met
• Accountable for performance metrics
• Accountable to develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio
• Collaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites
• Ensures oversight and line management of Clinical Research Manager (CRM) team within TA
• Leads team independently with supervision from CRD to high performance
• Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions.
• Ensures key talent development and retention
• Collaborates and works closely with other stakeholders in the TA in GCTO & GCD regional and headquarter teams, quality, finance, IT and HR
• Collaborates externally with investigators, regulators and vendors
• Member of the GCTO country leadership team
• Supports strategic initiatives across Global Clinical Development GCD and GCTO
• Supports local strategy development consistent with long-term corporate needs in conjunction with CRD.
• Together with direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and compliance
• This position impacts directly the country´s ability to reach business targets and objectives and ensures that productive collaboration with internal and external business partners are built.

Qualifications, Skills & Experience:

• Bachelor’s degree in science or equivalent healthcare experience
• Preferred: Advanced degree, (e.g., MSc, Ph.D, MBA)
• Minimum of 10 years´ experience in clinical trial organization
• Minimum of 2 years´ experience in a functional management position
• CRA , project management and CRM experience
• Line management experience
• Business and financial acumen
• Strategic thinking
• Ability to think cross-functionally and working across boundaries internationally
• Ability to identify problems, conflicts and opportunities early and lead, analyse mitigation plans and drive conflict resolution is critical
• Fluent in Local Language and business proficient in English (verbal and written) and excellent communication skills
• Sound ICH-GCP knowledge and knowledge of Good Documentation Practices
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• High emotional intelligence
• Strong leadership and negotiation skills

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Position Overview:

In this role, you will have the responsibility of overseeing the South Africa Payroll. Your expertise in South Africa payroll will be crucial in ensuring a seamless and efficient payroll process, as well as being instrumental in the payroll transformation. Additionally, you will have the opportunity to expand your knowledge and understanding of payroll in other countries. A strong regional team will be available to provide support and assistance in all aspects of your role. You will report to the Payroll Lead MER / EEMEA , joining a team of peers based regionally. The main office will be located in South Africa / Midrand (location can be flexible however)

For all activities, the Payroll Specialist demonstrates a continuous improvement mind-set to have issues solved at root cause as well as experience and a passion for delivering successful results with an inclusive team ethic. 

The Payroll Specialist South Africa is responsible for:

• Administer employee salaries, accurately calculating and processing payroll for all employees.
• Monitors the output of standard personnel and salary changes (with input from HR, Workday and other sources)
• Ensure an accurate and timely monthly, quarterly and year-end close, including the account reconciliations of payroll related balances.
• Expats and commuters processing, consultation on international remuneration with EY & Global Mobility.
• Maintain accurate filling and documentation of all relevant payroll data.
• Processing all monthly SARS payments on E-filing.
• Handle midyear tax reconciliations and submitting to SARS.
• Assist with annual audits, both internal and external, to ensure compliance and accuracy.
• Stay up to date with legislative changes within SA Payroll, ensuring adherence to all legal requirements.
• Identify opportunities for process improvement to ensure global standards and efficient operational delivery.
• Monitor the performance of third-party providers related to payroll, ensuring key performance indicators and risk management.
• Participation in projects and working groups.

Qualifications, Skills & Experience Required:

• Bachelor’s degree in finance, HR, or related field, in lieu of a degree, the equivalent in experience and evident of exceptional ability
• Minimum of 3 years of experience in payroll administration or a similar role, with a deep understanding of South Africa payroll regulations.
• sound knowledge and experience of multi-country payroll delivery and governance, is a plus.
• Strong knowledge of SARS regulations and experience with E-filing.
• Attention to detail and exceptional analytical skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong organizational and time management skills, with the ability to meet tight timelines.
• Fluent in English (written and spoken),

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Job Description

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.For certain studies, the Clinical Research Manager could be responsible for several countries in a cluster.

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to Therapeutic Area Head/Clinical Research Director/Country Clinical Quality Manager and or Clinical Trial Team (as appropriate)
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
• Collaborates internally with HQ functions and locally with Pharmacovigilance, Regulatory and Global Medical Affairs to align on key decisions in his/her studies. Global Human Health to be consulted as needed.
• As a customer-facing role, this position will build business relationships and represent our Company with investigators.
• Shares protocol-specific information and best practices across countries\clusters.

Qualifications, Skills & Experience

CORE Competency Expectations:

• Knowledge in Project Management and site management.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the Therapeutic Area Head or Clinical Research Director.
• Requires strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
• Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking

Behavioural Competency Expectations:

• Strong leadership skills that enable and drive alignment with the goals, purpose and mission.
• Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders.

Experience Requirements:

Required:

• 5-6 years of experience in clinical research
• Clinical Research Associate experience

Educational Requirements:

Required:

• Bachelor’s degree in science (or comparable)

Preferred:

• Advanced degree, (e.g., Master's degree, MD, PhD)

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Role Purpose

• Brings an analytics mindset to the commercial processes to ensure that business decisions are informed by data.
• The successful incumbent will undergo a comprehensive development program over a period of 24 months.

Role Responsibilities

• Helps with data stewardship and data governance.
• Helps define and manage data standards and access rules, work with 3rd party data stakeholders.
• Consult with business functions, extract and analyse relevant data from data information systems to assist in organizational decision making.
• Provide strategic commentary on information provided.
• Identify new data needs for stakeholders. Informs micro-targeting and personalization of campaigns.
• Assist in shaping data strategy. Serves as first point of contact for data sets within a domain and has a deep understanding of the data within the domain.
• Designs or will work with IT designers (depending on the tools) to deliver visualizations and descriptive reports to uncover.
• Insights to inform marketing execution and sales trends/competitor analysis.

Qualifications, Skills and Experience required:

• Undergraduate or post-graduate degree in Business Science (Finance/Economics), information management/Data Sciences, or STEM.
• Computer proficiency in MS Office suite (MS Word, Excel, Outlook and Power Point).
• Disabled candidates may apply.

COMPETENCIES:

Technical

• Master of data navigation.
• Helps with data navigation & promotes stewardship.
• Defines data quality standards and manages access rules.
• Visualization production expertise (e.g. Excel Advanced, Power BI etc.).
• Planning and Organisation.
• Communication skills.
• Business Acumen.
• Attention to detail.
• Good presentation skills.
• Good written and verbal communications skills.

Behavioural

• Foster Collaboration.
• Drive for results.
• High end interpersonal skills & Customer Centricity.
• Creativity & Innovation.
• Demonstrate Ethics & Integrity.