Johnson & Johnson Careers

• The Medical Affairs Director is accountable for providing clinical, medical, and scientific strategic leadership within the various areas and programs in the GHE (Global Health Equity) organization. Working in close collaboration with Global, Regional and Local cross-functional leaders, the Medical Director is responsible for establishing and implementing comprehensive scientific and programmatic strategies to advance health equity efforts in resource limited settings in key geographies, including high, middle and low-income countries. He/she participates in and supports diversity, equity, and inclusion strategic initiatives, particularly those activities that positively impact health outcomes in marginalized populations.
• The Medical Director will be directly responsible for scientific engagements with global stakeholders and key opinion leaders in a specific scientific area, as well as scientific publications plans, He/she is also responsible for facilitating and ensuring a consistent and compliant approach to Medical Affairs processes.
• The Medical Director establishes a practical strategy to address and to measure progress related to the impact of GHE programmatic initiatives on health outcomes across focus populations.
• The Medical Director will provide medical and strategic leadership for global medical education programs, medical and scientific communications, thought leader development and management, and research in support of priority disease areas and GHE programmatic initiatives.
• The Medical Director will be directly responsible for internal communication regarding medical affairs activities to internal stakeholders within J&J.

Tasks:

• Develops integrated medical and programmatic strategy and plans that align with prioritized global, regional and local operating company needs
• Provides medical and scientific insights to activities related to planning, execution and reporting of clinical studies, implementation research and health outcome research studies
• Leads external scientific and clinical engagements including global advisory boards, medical symposia, congress activities, and Medical Affairs -related collaborations and communications
• Leads internal processes for submission and review of scientific materials and studies of assigned products/areas, including the global publications planning process. For example: manuscripts, abstracts, posters, and papers as well as pre-launch global KOL communications and speaker development.
• Establishes a practical strategy to address and to measure progress related to the impact of GHE activities on health outcomes across focus populations
• Acts as a change agent, thought-leader, influencer & subject matter expert on health equity and inclusion, and the ways in which the organization can improve its service of other groups

Other duties:

• Provide ongoing review of clinical study data, final analysis and interpretation, in collaboration with the relevant global teams (SMT, Clinical Teams, CDT) as needed
• Serve as a disease area scientific and medical expert for internal and external stakeholders/functions.
• Serve as clinical expert for programmatic discussions, assessments, quality evaluations and partnerships.

Qualifications: Required Education: MD
Required Knowledge, Skills and Abilities:

• Global mindset and direct experience with diverse global settings; proven ability to partner cross- culturally/regionally preferred.
• Experience developing and managing relationships with thought or opinion leaders, policy makers, normative bodies, and other relevant organizations.
• In-depth knowledge of clinical research methodology, public health and/or implementation research, study data reviews and analysis.
• Excellent knowledge of study execution including safety management and regulatory requirements.
• A demonstrated track record leading highly cross-functional work teams.
• Highly innovative thinker with the ability to drive a complex and changing environment and effectively manage and resolve issues.
• Proven ability to effectively communicate scientific and medical information both orally and in writing for external audiences is required.
• Champion the highest standards of compliance, ethics, J&J Credo principles, and patient safety, putting patients at the center of all actions.
• Deep content knowledge of diversity, equity, and inclusiveness research base and best practices for organizations striving to become more diverse, equitable, and inclusive.

Preferred Knowledge, Skills and Abilities:

• MD (must) - public health experience is a plus
• Experience in mental health, behavioral health, community health
• In-depth knowledge of clinical research methodology, public health and/or implementation research, study data reviews and analysis.
• Excellent knowledge of study execution including safety management and regulatory requirements.
• A demonstrated track record leading highly cross-functional work teams.

• Plans, coordinates, and executes research programs conducted by Medical Affairs. Performs project management, safety reporting, data coordination/management and reporting/communication of results.

Duties & Responsibilities

• Administers medical affairs programs management, safety reporting, data coordination/management and reporting/communication of results (for example, publication, presentations, communication materials).
• Participates in developing policies and procedures for development and provision of medical, Research educational and technical materials in support of local and regional speakers upon unsolicited request.
• Develop and execute engagement plans with timely execution of identified stakeholders’ medical initiatives in the market.
• Organizes technical information and education regarding the safe and effective use of company products to health care providers and other customers.
• Plans clinical educational activities that facilitate learning regarding clinically relevant information to physicians, nurses, and other medical professionals.
• Screening and processing of unsolicited medical education grants for therapeutic and operational appropriateness.
• Supports medical operations. Participates in the company's drug surveillance program which includes following up on adverse reaction reports.
• Provides solutions surrounding legal liability and compliance with government regulations. Oversees quantitative and qualitative data analysis.
• Facilitates understanding of clinical trial data. Ensures the quality and integrity of the data generated from clinical trials.
• Maintains relationships with internal stakeholders to ensure the information integrity. Integrates appropriate information into training programs.
• Support country medical affairs strategy in line with global focus for Immunology, Oncology, and mental health portfolio, gather insights for assigned therapy lines.
• Peer 2 peer communication with external experts geared towards high level scientific discussions within the therapy area.
• Strategize, plan and execute local advisory group meetings.
• Provide internal team medical training and updates as required.
• Through knowledge, understanding and adherence of local laws and regulations including pharmaceutical code of conduct.

Qualifications: Experience Required

• Bachelors degree in medicine or equivalence
• At least 1 year minimum of MSL experience and in a multinational pharmaceutical industry
• Minimum 3 years of experience in Medical Affairs
• 80% customer facing time, 30% local travel – field-based position.
• Excellent interpersonal and communication skills
• Self-driven, highly motivated person & agile
• Excellent self-management skills
• Excellent communication and presentation skills, both written and verbal
• Desire to work as part of a small, cohesive, and collaborative team.
• Must exhibit behaviours aligned to the J&J Global Leadership Profile including but not limited to integrity-credo based actions, collaboration and teamwork, sense of urgency and results driven Must exhibit behaviours aligned to the J&J Leadership Imperatives: Connect, Shape, Lead, Deliver and Live Our Credo

Leadership Behaviors Required

• LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose
• CONNECT: Builds internal and external relationships based on respect, collaborates openly across boundaries and acts as a team player.
• SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change.
• Grow: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes.

Core Competencies Required:

• Self-driven and motivated to succeed.
• Strong team player
• Resilience and agile
• Demonstrate and role model leadership behaviours.
• Fluency in English and one or more local languages
• A self-starter and excellent problem-solver

Summary of the job:
The main tasks of Medical Science Liaison :

• Plans, coordinates, and executes research programs conducted by Medical Affairs. Performs project management, safety reporting, data coordination/management and reporting/communication of results.

Duties & Responsibilities

• Administers medical affairs programs management, safety reporting, data coordination/management and reporting/communication of results (for example, publication, presentations, communication materials).
• Participates in developing policies and procedures for development and provision of medical, Research educational and technical materials in support of local and regional speakers upon unsolicited request.
• Develop and execute engagement plans with timely execution of identified stakeholders’ medical initiatives in the market.
• Organizes technical information and education regarding the safe and effective use of company products to health care providers and other customers.
• Plans clinical educational activities that facilitate learning regarding clinically relevant information to physicians, nurses, and other medical professionals.
• Screening and processing of unsolicited medical education grants for therapeutic and operational appropriateness.
• Supports medical operations. Participates in the company's drug surveillance program which includes following up on adverse reaction reports.
• Provides solutions surrounding legal liability and compliance with government regulations. Oversees quantitative and qualitative data analysis.
• Facilitates understanding of clinical trial data. Ensures the quality and integrity of the data generated from clinical trials.
• Maintains relationships with internal stakeholders to ensure the information integrity. Integrates appropriate information into training programs.
• Support country medical affairs strategy in line with global focus for Immunology, Oncology, and mental health portfolio, gather insights for assigned therapy lines.
• Peer 2 peer communication with external experts geared towards high level scientific discussions within the therapy area.
• Strategize, plan and execute local advisory group meetings.
• Provide internal team medical training and updates as required.
• Through knowledge, understanding and adherence of local laws and regulations including pharmaceutical code of conduct.

Qualifications:
Experience Required

• Bachelors degree in medicine or equivalence
• At least 1 year minimum of MSL experience and in a multinational pharmaceutical industry
• 80% customer facing time, 30% local travel – field-based position.
• Excellent interpersonal and communication skills
• Self-driven, highly motivated person & agile
• Excellent self-management skills
• Excellent communication and presentation skills, both written and verbal
• Desire to work as part of a small, cohesive, and collaborative team.
• Must exhibit behaviours aligned to the J&J Global Leadership Profile including but not limited to integrity-credo based actions, collaboration and teamwork, sense of urgency and results driven Must exhibit behaviours aligned to the J&J Leadership Imperatives: Connect, Shape, Lead, Deliver and Live Our Credo

Leadership Behaviors Required

• LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose
• CONNECT: Builds internal and external relationships based on respect, collaborates openly across boundaries and acts as a team player.
• SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change.
• Grow: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes.

Core Competencies Required:

• Self-driven and motivated to succeed.
• Strong team player
• Resilience and agile
• Demonstrate and role model leadership behaviours.
• Fluency in English and one or more local languages
• A self-starter and excellent problem-solver

Job Purpose:

• Reporting to the Product Manager/Key Account Manager, you will be responsible for creating the right environment to achieve and maintain commercial success to our portfolio of oncology products.
• You will become a partner and solutions provider in these therapy areas for the healthcare providers in your defined territory and work with wholesalers, hospitals, private clinics, and retail pharmacies to ensure product availability.

The main duties and responsibilities of the position are:

•  Keep an updated mapping of key stakeholders in Oncology within your territory.
•  Visit key stakeholders/customers within your territory on a regular basis to inform and update them on our treatment options.
•  Effectively sell the value offering of Janssen Oncology products to meet the individual needs of all relevant customers within the cancer treatment space.
•  Become the expert in terms of knowledge and practical application in all aspects of the environment, relevant therapy areas, the company and competitor products.
•  Establish and manage KOL relationships.
•  Organize and present in local healthcare professional meetings, to promote the appropriate use of our products.
•  Drive promotional activities during national or local scientific congresses.
•  Ensure all activities follow the internal compliance guidelines and are documented accordingly.
•  Partner with sub-distributors, wholesalers, hospitals, private clinics and pharmacies to ensure product availability.
•  Provide market feedback to management in the form of activity and results reports and territory analyses.

Compliance Responsibilities:

•  Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects, and contracting vendors.
• Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied when planning projects, developing materials, executing projects, and contracting vendors.
•  Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description

Main interactions:

Internal

•  Key Account Managers
•  Market Access manager
•  Medical and Regulatory Affairs Managers
•  Other medical representatives and JKAMS
•  Country Manager

External

•  All relevant healthcare professionals
•  Key Opinion Leaders
•  Retail / Wholesale Pharmacies / Hospital Pharmacies / Key accounts
•  NHIF and other payers.
•  MOH

Qualifications
We’d love to hear from YOU, if you have:

•  A minimum of 5 years’ experience in driving pharmaceutical stakeholder engagement, sales, and marketing on assigned products and territory, ideally in healthcare industry in Kenya.
•  Good knowledge of Kenya oncology healthcare industry
•  Education, University Degree in relevant field with additional years of professional experience.
•  Proven business development manager who is used to working to targets.
•  Proven track record in sales, business development and winning new business.
•  Proven track record of increasing revenue through generation of demand
•  Strong account management and relationship building skills.
•  Ability to plan and prioritize own work to meet quality standards and deadlines.
•  Excellent communication and presentation skills, territory management and ability to influence customers and internal stakeholders.
•  Desire to work as part of a small, cohesive, and collaborative team.
•  Must exhibit behaviours aligned to the J&J Global Leadership Profile including but not limited to integrity-credo based actions, collaboration and teamwork, sense of urgency and results driven.
•  Must exhibit behaviours aligned to the J&J Leadership Imperatives: Connect, Shape, Lead, Deliver and Live Our Credo

Core competencies required for this role:

•  Self-driven motivated and ability to deliver the assigned KPIs.
•  Strong team player
•  Resilience
•  Fluency in English and one or more local languages
•  Ideally with an entrepreneurial mindset, a self-starter and excellent problem-solver

Job purpose

• The position is responsible for the regional coordination of clinical trial management activities for outsourced and/or collaborative trials from start-up through study closure in alignment with the Janssen Standard Operating Procedures and applicable Health Authority Regulations.
• Responsibilities primarily focus on investigational site capacity building, Good Clinical Practice (GCP) implementation and quality oversight in collaboration with CRO in region, facilitate regulatory approvals in collaboration with global Regulatory Affairs; oversight of Investigational Medicinal Product (IMP) import and storage in the region; Good Participatory Practice (GPP) implementation and oversight.
• Responsibilities may also include oversight of regional vendors or suppliers.
• The position requires strong operational expertise and knowledge of local clinical research regulations and health care systems.
• This position is a member of the Janssen team – partners with CRO/Partner Team and interfaces with other Global Development (GD) functions, Study Responsible Physician and Global Clinical Operations (GCO) or CRO/vendor staff and Study Sites (if applicable).
• Reports for the project to the GD Trial Leader (GTL) and is member of the Cross-functional Trial Team, led by the GTL.

The responsibilities & the impact YOU will have:

The main duties and responsibilities of the position are:

•  Assesses the need to build capacity and contributes to capacity building where needed, including follow up on basic infrastructure building for site, local lab and/or local pharmacy/depot.
• Demonstrates deep knowledge of global (ICH) and different local regulations and guidelines in the region, as well as Janssen Policies, SOP’s and study protocols.
• Invests in relationship building with local stakeholders to strengthen and optimize the regulatory framework for clinical research including Genetically Modified Organism based IMP and Material Transfer Agreements for biological samples.
• Helps Ensure appropriate safety reporting procedures are in place per Janssen Policies, and applicable local regulations, and acts as liaison to Global Medical Safety (GMS) and Local Safety Officer (LSO)
• Supports Review and approval of the Local IMP label; manage local depot quality and issue handling; identify import license requirements and support IMP import.
• Contribute to local GPP implementation based on central GPP guidelines, and practical GCP experience/adherence. May contribute to local community engagement strategies.
• Provides sponsor oversight and Support of clinical trial execution in the region by means of:
  • Trial execution in the region is in compliance with Janssen SOP’s and policies, international and local regulations, and are aligned with local health care system. And protocol compliance
  • Participation in preparation for, and conduct of, Health Authority inspections and internal Quality Assurance audits. Support CRO/partner to ensure that trial sites are continuously inspection ready. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
  • Reviews (On-Site Compliance) Monitoring Visit Reports submitted by the CRO and ensures action items are followed up in time and with the appropriate quality. Identify trends across countries within the region and initiate corrective actions in collaboration with CRO and Janssen internal functions.
• Performs (or participates if initiated by CRO) lessons learned activities and knowledge sharing across in- house (leverage with GCO) and the outsourced protocols and with internal and external stakeholders relevant to the region.
• Support the global team in Management of regional vendors and their issue handling and contribute to contingency/mitigation plans where needed.
• Act as the Sponsor contact person for the local teams of the partners and/or CRO. Establish and maintain excellent working relationships with internal and external stakeholders. Demonstrates deep knowledge of protocol and procedures, adequate therapeutic area knowledge, and practical implementation in the region.
• May collaborate with CRO/Partner for:
  • Country protocol feasibility and site feasibility assessment
  • Provide regional intelligence/guidance to study teams in regard to actual or forecasted CRO Out of Pocket Expenses or other vendor related expenses linked to the region and review assigned vendor invoices/spend on ad hoc basis and as applicable.
  • Contribute to study-specific documents to account for region specific requirements or needs, such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan
  • Review and customize appropriate trial-specific training materials and requirements, making them available and appropriate to the regional monitors and site study staff and delivering training as needed. Contribute to Regional Investigator Meetings, in close collaboration CRO/Partner staff as well as GTL.
• Acts as a Subject Matter Expert with regional expertise including Clinical Research Capability development by GPH, and external partners. Providing regional insights by connecting with regional stakeholders/groups.

We’d love to hear from YOU, if you have:

• BS degree or equivalent required, preferably in Medical or Life Sciences (e.g., Medical Doctor, Biology, Chemistry, Biochemistry, Nursing, PharmD),
• Minimum of 6-8 years Clinical Trial Management experience however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Requires clinical research operational knowledge, strong project planning/management and effective communication skills.
• Knowledge of global and regional regulatory environment and regulations.
• Should be flexible and have experience and ability in managing regional teams both in resource limited settings (if applicable) and in a virtual environment.
• Proven track record in successfully managing trials from start-up to database lock.
• Experience with supervision of CROs/vendors is required.
• Strong leadership skills.
• Solid communication and computer skills required.
• Proficient in speaking and writing English language. Excellent written and oral communication skills.
• Strong experience in mentoring/coaching and providing training to local teams, such as CRO representatives, partners, and site staff.
• Demonstrated ability to lead initiative/small teams.
• Strong analytic skills and effectiveness in seeking solutions to problems.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness.
• Specific therapeutic area experience may be required.
• Must be willing to travel 50% of role.

This position is a member of the Janssen team – partners with CRO/Partner Team and interfaces with other Global Development (GD) functions, Study Responsible Physician and Global Clinical Operations (GCO) or CRO/vendor staff and Study Sites (if applicable). He/she reports for the project to the GD Trial Leader (GTL) and is member of the Cross-functional Trial Team, led by the GTL

The Responsibilities & The Impact YOU Will Have

The main duties and responsibilities of the position are:

• Assesses the need to build capacity and contributes to capacity building where needed, including follow up on basic infrastructure building for site, local lab and/or local pharmacy/depot
• Demonstrates deep knowledge of global (ICH) and different local regulations and guidelines in the region, as well as Janssen Policies, SOP’s and study protocols
• Invests in relationship building with local stakeholders to strengthen and optimize the regulatory framework for clinical research including Genetically Modified Organism based IMP and Material Transfer Agreements for biological samples
• Helps Ensure appropriate safety reporting procedures are in place per Janssen Policies, and applicable local regulations, and acts as liaison to Global Medical Safety (GMS) and Local Safety Officer (LSO)
• Supports Review and approval of the Local IMP label; manage local depot quality and issue handling; identify import license requirements and support IMP import
• Contribute to local GPP implementation based on central GPP guidelines, and practical GCP experience/adherence. May contribute to local community engagement strategies
• Provides sponsor oversight and Support of clinical trial execution in the region by means of:
  
• Trial execution in the region is in compliance with Janssen SOP’s and policies, international and local regulations, and are aligned with local health care system and protocol compliance
• Participation in preparation for, and conduct of, Health Authority inspections and internal Quality Assurance audits. Support CRO/partner to ensure that trial sites are continuously inspection ready. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools
• Reviews (On-Site Compliance) Monitoring Visit Reports submitted by the CRO and ensures action items are followed up in time and with the appropriate quality. Identify trends across countries within the region and initiate corrective actions in collaboration with CRO and Janssen internal functions
• Performs (or participates if initiated by CRO) lessons learned activities and knowledge sharing across in- house (leverage with GCO) and the outsourced protocols and with internal and external stakeholders relevant to the region
• Support the global team in Management of regional vendors and their issue handling, and contribute to contingency/mitigation plans where needed
• Act as the Sponsor contact person for the local teams of the partners and/or CRO.

Establish and maintain excellent working relationships with internal and external stakeholders. Demonstrates deep knowledge of protocol and procedures, adequate therapeutic area knowledge, and practical implementation in the region

• May collaborate with CRO/Partner for:
  
• Country protocol feasibility and site feasibility assessment
• Provide regional intelligence/guidance to study teams in regard to actual or forecasted CRO Out of Pocket Expenses or other vendor related expenses linked to the region and review assigned vendor invoices/spend on ad hoc basis and as applicable
• Contribute to study-specific documents to account for region specific requirements or needs, such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan
• Review and customize appropriate trial-specific training materials and requirements, making them available and appropriate to the regional monitors and site study staff and delivering training as needed. Contribute to Regional Investigator Meetings, in close collaboration CRO/Partner staff as well as GTL
• Acts as a Subject Matter Expert with regional expertise including Clinical Research Capability development by GPH, and external partners. Providing regional insights by connecting with regional stakeholders/groups

Principal Relationships

• Clinical Trial Manager, GD Trial Leader, GD Program Leader, Functional Management, R&D Country Managers, Regional Therapeutic Area Experts, Global Data Manager, Central Monitoring Managers,
• Clinical Supply Chain, Quality Management & Training group, Clinical Trial Regulatory Liaison, ESP Manager, Study Responsible Physician/Scientist, HCC, GPH team members
• Contacts outside the company: CRO Project Manager, CRO Site Manager, partners and/or NGO’s as applicable, study site staff as needed, and regional stakeholders/ groups

Qualifications

• BS degree or equivalent required, preferably in Medical or Life Sciences (e.g., Medical Doctor, Biology, Chemistry, Biochemistry, Nursing, PharmD),
• Minimum of 6 years clinical trial management experience however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
• Requires clinical research operational knowledge, strong project planning/management and effective communication skills
• Knowledge of global and regional regulatory environment and regulations
• Should be flexible and have experience and ability in managing regional teams both in resource limited settings (if applicable) and in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is required
• Strong leadership skills. Solid communication and computer skills required. Proficient in speaking and writing English language. Excellent written and oral communication skills
• Strong experience in mentoring/coaching and providing training to local teams, such as CRO representatives, partners and site staff. Demonstrated ability to lead initiative/small teams.
• Strong analytic skills and effectiveness in seeking solutions to issues
• Effective leadership skills and proven ability to foster team productivity and cohesiveness
• Specific therapeutic area experience may be required depending on the position.

Overall Purpose of this Job:

The PM/KAM will be responsible for creating the right environment to achieve and maintain market access to our new portfolio of oncology and hematology products treating debilitating disease areas such as: Multiple Myeloma, NHL, CLL, and Prostate Cancer. The PM/KAM will also become an expert on mapping, understanding the patient pathway and ultimately providing solutions to overcome the relevant barriers in the healthcare system that currently limits prescribers and patients gaining timely and appropriate access to our new products.

The responsibilities & the impact YOU will have:

• Produce and develop an insight driven product plan to deliver a flawless launch of the new product(s).

• Understand the market environment to identify business opportunities within the complex & changing healthcare structures.

• Create environments and advocates that will assist in peer to peer sharing of clinical experience within both secondary and primary care settings.

• Develop and align brand value propositions with local health economy objectives.

• Influence preferential timely formulary decisions and other regional/national networks to establish market access for the product(s).

• Advance notification of product(s) and prices according to local laws

• Establish and manage KOL relationships.

• Ensure local adaptation of relevant EMEA generated promotional materials prior to launch.

Approved Products (promotional)

• Effectively sell the value offering of your product(s) to meet the individual needs of all relevant customers within the local health economy.

Become the expert in terms of knowledge and practical application in all aspects of the environment, relevant therapy areas, the company and competitor products.

• Account manage your customers including payers, prescribers and other decision-makers – typically involving clinicians, oncology specialist nurses and pharmacists at all levels.

• Become the oncology / hematology “go-to” account manager for your customers, establishing the top ranked customer feedback against other industry sales professionals.

• Report spontaneous unsolicited AE/PQC & specials situations from ALL sources within 24 hours or the following business day and support where requested in conducting follow ups.

Qualifications

We’d love to hear from YOU, if you have:

Required:

• A minimum of a Bachelor’s degree is required. Pharmacy degrees are preferable.

• At least 5 years of Sales Experience in pharmaceuticals.

• Fluency in English and one other local language.

• Proven track record in a field sales role and with a passion for delivering quality healthcare solutions.

• Strong key account management / implementation skills.

• creative thinker: a top performer with determination, passion and high levels of motivation.

• The ability to handle complex technical information and business challenges.

• Excellent team working skills with both sales and cross functional colleagues.

• The ability to identify new opportunities and develop solutions to manage competitor activity.

• Proven business acumen - strategic thinking and the ability to deliver innovative customer solutions.

• Proven ability to develop customers at all levels.

• Strong understanding of the changing healthcare environment.

• Results and performance driven with pro-active, 'can do' attitude.

• Flexibility, in order to respond to changing business needs.

• Negotiation and facilitation skills.

• Willingness to engage, learn and share best practice across the team and organization.

You in the Role

• Embed a service design perspective in design for behavior and systems change on cross-functional teams in GPH
• Deliver human-centered design research, strategy, and innovation practices to address a business need in the Healthcare ecosystem in low- and middle-income countries, collaborating with patients, caregivers, providers, and external partners
• Lead teams in synthesis of research, developing engaging insights, compelling narratives, and strategic frameworks to influence the development of equitable care experiences
• Enable the effective transition of these insights and strategies into implementation with local ownership through participatory methods at the global and local levels
• Increase the value of design by continuously advancing our methods, helping to shape design for health equity and bring leading design practices as a differentiator to critical funding and implementing partners on the global stage

Requirements

Qualifications

• At least a bachelor’s degree in design or related field
• 8+ years of Service and/or Business Design leadership-related experience in shaping Social Entrepreneurship, Social Innovation or Public Health Programming
• Experience in building both digital and human-delivered services with community engagement and health promotion activities is a plus
• Very skilled in facilitation and participatory design practices that enable others to own the design process - designing ‘with’ and not ‘for’, and enabling others to implement solutions moving forward
• Confident qualitative research background with exposure to quantitative methodologies, developing and translating insights into desirable care futures, informing implementable tactics in regulated public health environments
• Strong visual storytelling, and clear, concise writing and speaking skills are required
• English fluency is required

Position Summary

The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM II is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The LTM II is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles. The LTM II may have some site management responsibilities.

The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.

The Responsibilities & The Impact YOU Will Have

The main duties and responsibilities of the position are:

• Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
• Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
• Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs
• Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
• Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress
• Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
• May submit requests for vendor services and may support vendor selection.
• In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered -within budget. Adheres to finance reporting deliverables and timelines.
• Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
• Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. Implementation of study amendment-and changes in study related processes).
• Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed
• Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
• Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
• Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements
• Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
• Complies with relevant training requirements.
• Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
• Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
• Actively contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
• Conducts accompanied site visits with SM as delegated by FM.
• May assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
• May represents functional area in process initiatives as required

Principal Relationships

• Primary Reporting Structure: Reports to a Functional Manager
• Primary interfaces: Functional Manager/CRM, CTAs, SMs, CTM/GTLs, Study Responsible Physicians (SRP), Quality & Compliance Managers/Specialists, Local Safety Officer
• Other Internal Interfaces: R&D Country Head, Regional Therapeutic Area Experts (RTAEs), Contracts & Grants, CTM/GTL, R&D study team (e.g., SRP), data management and Medical Affairs (when applicable)
• External Interfaces: Trial Site Personnel, external vendor representatives, Ethics Committee and others as required

Qualifications

We’d love to hear from YOU, if you have:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), however other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements.
• Willingness to travel with occasional overnight stay away from home.
• Solid leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
• Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.
• Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel.