Job Vacancies at MSD South Africa

Job Description

• Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Brief Description of Position:

• Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
• The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
• The person acts as process Subject Matter Expert (SME), making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior CTCs.

Responsibilities include, but are not limited to:

Trial and site administration:

• Track (e.g., essential documents) and report (e.g., Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document management:

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents

 Regulatory & Site Start-Up responsibilities:

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments:

• Collaborate with finance/budgeting representatives for:
• Develop, control, update and close-out country and site budgets (including Split site budget)
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures
• Monitor and track adherence and disclosures,
• Maintain tracking tools
• Obtain and process FCPA documentation in a timely manner

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Quality & Oversight:

• Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Mentors / buddies junior CTCs (including, but not limited to process requirements)

Qualifications, Skills and Experience:

Skills:

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
•   Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
•   Hands on knowledge of Good Documentation Practices
•   Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
•   ICH-GCP Knowledge appropriate to role
•   Excellent negotiation skills for CTCs in finance area
•   Highly effective time management, organizational and interpersonal skills, conflict management
•   Effective communication with external customers (e.g., sites and investigators)
•   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, both internally and externally.
•   Able to work independently taking full ownership of delegated tasks
•   Proactive attitude to solving problems / proposing solutions
•   Positive mindset, growth mindset
•   Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Qualification & Experience:

•   Minimum 3 - 5 years in Clinical Research or relevant healthcare experience
•   Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

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Job Description

• Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Brief Description of Position:

• Our Clinical Research Team is currently looking for a new Clinical Trial Coordinator (Vendor & Ancillary Supply Management).
• Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
• The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities include, but are not limited to:
Trial and site administration:

• Track (e.g., essential documents) and report (e.g., Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document management:

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

 Budgeting, Agreement and Payments:

• Collaborate with finance/budgeting representatives for:
• Develop, control, update and close-out country and site budgets (including Split site budget)
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures
• Monitor and track adherence and disclosures
• Maintain tracking tools
• Obtain and process FCPA documentation in a timely manner

 Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)o Support local investigator meetings

Qualifications, Skills and Experience:

Skills:

•  Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
•  Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
•  Hands on knowledge of Good Documentation Practices
•  Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
•  ICH-GCP Knowledge appropriate to role
•  Excellent negotiation skills for CTCs in finance area
•  Effective time management, organizational and interpersonal skills, conflict management
•  Effective communication with external customers (e.g. sites and investigators)
•  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, both internally and externally.
•  Able to work independently
•  Proactive attitude to solving problems / proposing solutions
•  Positive mindset, growth mindset

Qualification & Experience:

•  Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

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Job Description

• Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Brief Description of Position:

• This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
• Responsibilities include, but are not limited to:
•  Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
•  Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles.
•  Executes and oversees clinical trial country submissions and approvals for assigned protocols.
•  Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
•  Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
•  Contributes to the development of local SOPs. Oversees CTCs as applicable.
•  Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.
•  Provide support and oversight to local vendors as applicable.
•  Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
•  Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
•  Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
•  Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
•  Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
•  Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
•  Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Qualifications, Skills and Experience:

Core competencies:

•  Expertise of core clinical systems, tools and metrics
•  Excellent verbal and written influrencing and training/mentoring skills, in local language and English
•  Strong coordination and organizational skills
•  Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
•  Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.
•  Ability to make decisions independently with limited oversight from Sr.COM or manager.
•  Requires strong understanding of local regulatory environment
•  Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
•  Ability to lead a team of CTCs as applicable

Behavioral Competency Expectations:

•  Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
•  Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
•  High sense of accountability and urgency in order to properly prioritize deliverables
•  Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
•  Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
•  Positive mindset, growth mindset, capable of working independently and being self-driven
•  Able to directly influence site staff

Experience Requirements:

•  5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Educational Requirements:

•  Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

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Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. 

Role Summary

• The South Africa (SA) Medical Director (CMD) is the Senior Medical Leader for our company in a country and serves as the leader of the medical affairs organization in their geography

CMD is the primary country level contact for Medical Affairs (MA) and has the following key responsibilities:

• Develops and executes the MA strategy for the country.
• Creates and maintains a high-performing, highly compliant MA organization for the country
• Manages the entire portfolio for our company, allocates resources balancing global and local priorities 
• Represents {the research arm of the Company, or Medical Affairs} in the country Leadership Team and in cross-functional collaborations with other functions, Human Health (HH), and others
• Communicates accomplishments, opportunities, and needs of the country to regional and/or global stakeholders
• Represents our company in external activities requiring the leadership and expertise of the country’s Senior Medical Leader

Responsibilities and Primary Activities

Leadership and Management of the Medical Affairs Organization

People

• Proactively manages and develops talent
• Proactively identifies new opportunities and gaps vs. emerging needs and addresses in a timely manner by reallocating and training of existing staff and/or external recruitment
• Creates an empowering, compliant, collaborative, and innovation-focused work environment
• Builds a culture of quality and compliance through training, oversight, and collaboration

Country Medical Affairs Plans (CMAPs)

• Strategically develops, executes, and delivers CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities
• Ensures alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs)
• Manages the country-developed Protocol Concept Sheets (PCS), obtains regional and global approvals for new local data generation activities, and manages their execution

Medical Affairs Management

• Provides oversight to the country medical information team, establishes processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materials
• Manages approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.)
• Oversees all activities of local medical department employees
• Oversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO)

Collaboration With Key Internal Stakeholders

• The CMD represents Medical Affairs in cross-functional leadership teams and collaborations and advocates for the interests of the country with regional and global colleagues

Country Leadership Team

• Represents Medical Affairs and is the “medical voice” in the country executive management team

Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA)

• Supports GCTO when requested
• Manages the submission and roles in the conduct of investigator-initiated studies
• Leads country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests

Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH, and Policy

• Interacts with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies
• Collaborates with CORE, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for our company’s entire portfolio of medicines and vaccines
• Provides medical expertise to the commercial product teams, ensuring the scientific and medical value of our company’s products across all therapy areas

Engagement With Key External Stakeholders

The CMD represents our company as an executive leader and scientific expert to the external community.

• Serves as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions, and the broader scientific community to lead and execute the medical research and implementation strategy for our company’s innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, scientific leader (SL) engagements, webinars, and presentations)
• Collaborates with CORE, Market Access, and Commercial colleagues to engage payers, policymakers, and other decision makers in support of our company’s innovative portfolio of medicines and vaccines
• Builds a network of key scientific leaders in areas of relevance to current and anticipated needs
• Develops and/or fosters relationships with external stakeholders to ensure that robust local insights from health care providers (HCPs) and patients are gathered and integrated into local, regional, and/or global strategies, plans, and tactics, enabling the generation of data needed by payers, physicians, and patients to properly understand and value our innovative medicines and vaccines
• Participates in outcomes research/health economics engagements with national payers, Health Technology Assessment (HTA) or regulatory agencies, in coordination with CORE, Market Access, and Commercial colleagues
• Provides scientific subject matter expertise for media relations and public affairs to country Communications, Corporate/External Affairs, and Public Relations teams and serves as official spokesperson for scientific matters

Required Qualifications, Skills, & Experience

Minimum

• MD or equivalent degree
• Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success: [refer to table below for requirements by type of role]
• People-management experience: [refer to table below for requirements by type of role]
• Demonstrated organizational skills, including ability to set goals and align priorities
• Deep experience in our company’s therapeutic areas of interest (e.g., oncology, infectious diseases treatment, vaccines, or specialty care)
• Budget management experience

Preferred

• Additional advanced degrees, entry on a specialist register (pharmaceutical medicine or a relevant clinical specialty) and a current ‘license to practice’ (strong plusses)
• Specialty clinical training (e.g., a residency +/- fellowship)