Job Vacancies at Johnson & Johnson

Your key responsibilities:

• Prepare R programming scripts to generate NONMEM analysis input dataset(s) for PK and/or PD analysis, based on requests from PM leader or Modeling leader. During dataset generation, PM support also modifies the variable definition file (PM leader or CPP leader is the main author of this document) which clearly defines each variable within this dataset with any additional information as they see fit. The NONMEM input dataset(s) created could be for interim or final analysis. The source used could be interim (uncleaned) or final SDTM/ADAM datasets or in sources in other formats, in some cases extensive data cleaning and complex calculations are needed.
• Upon request, QC NONMEM input dataset(s) generated by another PM support colleague. Log which QC script is used, which subjects were checked per study, what other aspects were checked within the dataset, the findings of the QC and the follow-up actions of those findings in a QC document.
• Generate e-submission package for NONMEM (or other modelling type) analysis. In general, the package includes NONMEM input datasets, NONMEM control file, output parameter files, output table files and other files, in addition to supporting documents such as define and var-names-descr files. PM support renames the files provided by PM leader or CPP leader so they fit the naming convention requirements for e-submission package if needed, converts these files into the appropriate formats, and places them into the right folder structure then links them to the define and var-names-descr files. PM support works closely with EPOD team to ensure the e-submission package has the right structure, accurate formats and being placed in the right assembly server directory.
• Interact with other departments (including but not limited to Data Management, Programming, bio-analytical teams, Regulatory) and external Vendors to communicate the needs of CPP in data collection, data formatting, data representation and cross departmental trainings if needed. Promote better understanding across different departments.
• Improve CPP internal processes in dataset creation, dataset QC (e.g. a standard QC R script with a checklist) and e-submission package preparation (e.g. R script which can automate the linking of documents).
• Experience with data plotting in R is desired (e.g. ggplot2).
• Experience with R shiny is a plus.
• Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements

QUALIFICATIONS

We would love to hear from YOU, if you have:

Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume.

• B.S. Degree or equivalent with 3 to 5 years of experience in pharmaceutical industry or M.S. Degree with 1-2 years of experience in pharmaceutical industry.
• Expertise with R programming language.
• Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM
• Knowledge of principles of non-linear mixed effect modelling
• A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts
• Good written and oral communication skills
• Ability to build and improve working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently in a timely manner (planning and organizing)
• Attention to detail
• Contributing to the organization assuming responsibility and accountability for successfully completing assignments or tasks (delivery of results)
• Actively identifying new areas for learning and application to the job (continuous learning)
• Good sense of cultural sensitivity and diversity (cultural diversity)
• Self-motivated with the ability to work independently with minimal direction (personal accountability)
• Estimated travel of about 5% of time

go to method of application »

Key Responsibilities:

• Execute identified projects in alignment with business priorities using Agile principles (Sprint Planning, Kanban Usage, Stand-Ups, Retrospective) to maximize value, speed and efficiency.
• Lead sourcing events, evaluate results, communicate with suppliers and interface with contracting.
• Conduct supplier negotiations.
• Partner with Category Leads, Business Engagement Leads and Business Partners.
• Support the development of category strategies by providing input and expertise, conduct sourcing activities, project management and implementation efforts.

QUALIFICATIONS

Education:

• A Bachelor’s Degree is preferred.
• A minimum of 5 years of category or business experience.

Experience and Skills:

Required:

• Project management
• Analytical skills
• Experience in Sourcing (RFPs, targeted negotiations)
• Communication skills and ability to interact with multiple teams and levels across the Organization.
• Working knowledge of Procurement systems is preferred.
• Proficiency in English, another language is an advantage.

go to method of application »

Key Responsibilities:

• Acts as primary local company contact for assigned sites for specific trials.
• May participate in site feasibility and/or pre-trial site assessment visits
• Attends/participates in investigator meetings as needed.
• Responsible for performing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
• Supports with site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
• Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Arranges for the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and detailed as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Maintains complete, accurate and timely data and essential documents in relevant IT systems used for trial management.
• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
• Attends regularly scheduled team meetings and trainings.
• Follows relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
• Prepares trial sites for close out, conduct final close out visit.
• Tracks costs at site level and ensure payments are made, if applicable.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
• Acts as a point of contact in site management practices.
• May contribute to process improvement and training.

QUALIFICATIONS

Education and Experience Requirements:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required!
• A minimum of 1 year of clinical trial monitoring experience. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Strong understanding of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel up to 75% with occasional overnight stay away from home.
• Flexibility to work from J&J Johannesburg office 3 days per week.
• Proficient in speaking and writing the country language and English. Good written and oral communication.

go to method of application »

Overall purpose of job:

To be a therapeutic area scientific expert, responsible for discussing our products, patients’ treatment trends and studies in the therapeutic areas in which we are involved, on a peer-to-peer basis with a defined audience of Leading Specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other stakeholders) and to be considered a trusted scientific counterpart and partner.

To maximize company product value through high scientific quality communication with Leading Specialists on a peer-to-peer basis. Through activities in line with the Medical Affairs Plan, the MSL is jointly responsible for the realization of short-term and long-term company goals.

Key areas of responsibility

To keep abreast of  medical and scientific knowledge.

• Continuously update their knowledge of products, patient’s treatment trends and clinical activities and studies within the therapeutic area and patient`s treatment trends in the region
• Identify evolving scientific concepts with future clinical implications

Development and maintenance of a  contact network with Leading Specialists .

• Understand their needs, key value drivers, practical treatment patterns and scientific activities within the therapeutic area
• Develop and execute an external stakeholder management plan in close collaboration and coordination with other functions including: MAF, Medical Education, GCO, HEMAR, Commercial
• Communicate the value of company products, contribute to e.g. market access activities and formulary discussions
• Through scientific interactions, champion the medical value of our products fairly based on the risk-benefit profile of our drugs and contribute to the fostering of innovative approaches
• Represent the company to other therapeutic area stakeholders including professional associations and patient organisations in cooperation with Medical Advisor(s)/Medical Director
• Recognize and nurture relationships with rising stars within the scientific community

Proactive and reactive communication  of medical scientific data to Leading Specialists and broader external health-care related audiences:

• Communicate directly and proactively scientific information on our products within the approved label
• Communicate non-promotional general information about our company, including pipeline, research and development programs and other relevant information
• Respond to unsolicited scientific queries from customers for approved products and products/indications in development, based on Medical Affairs and Medical Information documents
• Use digital technologies and new media to support proactive and reactive communication

Organization and participation in  Medical Education activities:

• Identify/support/educate speakers
• Build Medical Education programs with scientific third parties

Organization and participation in  Advisory Boards  in cooperation with Medical Advisor/Medical Director

Qualification & Experience

• Scientific degree: Medical Doctor, Pharmaceutical or Nature Science university degree
• Deep knowledge of the therapeutic area, strength in research and interpretation of medical data
• Relevant work experience, scientific acumen and communication skills in order to be accepted by Leading Specialists in peer-to-peer relationship
• Awareness of business strategy and high customer focus with an understanding of the importance of business results
• Innovative, able to work in a matrix and coordinate and drive a complex and changing environment
• Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide

Special requirements:

• Deep scientific knowledge in the therapeutic area
• Communication and presentation skills
• Business acumen
• Teamwork, leadership and influencing skills