Career Opportunities at Johnson & Johnson

Position Summary:

• A Site Manager II (SM II) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager II is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.

The main duties and responsibilities of the position are:

•  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 executing 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.
•  Contributes to 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 documented 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 systems utilized 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.
•  Complies with 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 Compliance Monitoring Visit (OSCMV).
•  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 be assigned as a coach and mentor to a less experienced site manager.
•  May contribute to process improvement and training.
•  Leads and/or participates in special initiatives as assigned.
•  May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”.

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.
•  A minimum of 2 years of clinical trial monitoring experience is preferred, 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.
•  Strong working knowledge 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 with occasional overnight stay away from home.
•  Proficient in speaking and writing the country language and English. Good written and oral communication.

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Job purpose

• The Medical Science Liaison (MSL) holds primary responsibility for the execution of the Medical Affairs

Plan. They are the point of contact for Key Opinion Leaders (KOLs) in a given territory and help answer their medical, scientific and research needs within specific guidelines.

The responsibilities & the impact YOU will have:

The main duties and responsibilities of the position are:  

•  To keep abreast of the latest medical and scientific knowledge in the therapeutic area
•  To develop and maintain a contact network with Leading Specialists
•  To provide strategic input to the company medical affairs plan & business decision-making
•  Communicate actively and reactively medical scientific data to leading specialists
•  Organize/coordinate and participate in Medical Education activities.
•  Organize and participate in Advisory Boards in cooperation with Medical Advisor/Medical Director.
•  Provide scientific support to company Sales Representatives such as training, scientific communication with leading specialists.
•  Support Medical Affairs study execution.
•  Gain valuable insight through scientific interactions into treatment patterns, and scientific activities in the therapeutic area and provide input to the company Medical Affairs Plan / business decision-making.
•   Champion medical benefits of products and contribute to foster innovative therapeutic approaches to benefit patients through scientific interactions with leading specialists.

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

• Preferably Scientific Degree: Medical Doctor, Pharmaceutical or Nature Science university degree
• or related qualification Science degree: MBChB/MBBCh, PhD, Masters or Pharmacist Prefer at least 2 years working experience in pharmaceutical industry or research company and with competency in a project management capacity.
•  Medical and clinical experience (preferred)
•  Deep scientific knowledge on the therapeutic area
•  Excellent communication skills
•  Business Acumen
•  Ability to work within a matrix – to work independently, as well as part of a team

Key competencies

•  Interpersonal skills /leadership
•  Highly motivated
•  Ability to travel.
•  Like customer relationship building
•  Strong collaborator
•  Problem solving
•  Good communicator
•  Project management (Lead/Shape/Connect)

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Job purpose

•   To represent Janssen Pharmaceutica and promote the product portfolio determined by the company in the therapeutic area/s in the allocated territory.

The responsibilities & the impact YOU will have:

The main duties and responsibilities of the position are:

  Business Area Performance:

•   Conduct all activities in a CREDO based manner and maintain compliance to HCC, industry, and company standards to drive business performance.
•   Act as an ambassador for Janssen Pharmaceutica (Pty) Ltd
•   Meet or exceed annual sales targets as determined in the assigned incentive targets by quarter for the financial year and be accountable for results.
•   Effectively communicate and implement strategies as determined by the BM’s.
•   Accountability and management of territory through iConnect & VEEVA (targeting and segmentation, call planning and recording, updating of customer lists and other requirements as communicated when determined by BU)
•   CIE metric achievement as determined by the SM, BUH, and CIE team to meet business requirements to reach HCP customer base with the correct frequency, channel and content.
•   Interact with correctly targeted customers through approved channels – virtual or physically to build relationships, gather market in intelligence, deliver key strategic messages and deliver key value-add to customers.
•   Conduct in-service training as required.
•   Completes administrative responsibilities efficiently and as per established deadlines.
•   Sales force effectiveness by analysing sales, customer, and activity data to monitor progress against objectives and communicate information to SM & BM’s; implement corrective action where necessary.
•   Develops a territory coverage plan that maximizes selling time with all account professionals, while coordinating efforts with company counterparts, to ensure good coverage and continuous selling effort.
•   Collaboration with BMs to ensure correct implementation of strategy and activities.
•   Organize and conduct promotional events and promote Janssen products in a compliant manner such as business meals, group meetings or other as determined by the BU requirements.
•   Timeously input all required data into iConnect as requested and as business need is determined.
•   Effectively incorporate Janssen selling skills incl. but not limited to AIDiNC selling process.
•   Actively participate in ongoing and required knowledge assessments pertaining to strategy, clinical trials, product and competitor with an achievement of required company pass rates (80%)
•   Taking accountability for enhancement of own knowledge pertaining to the role through ongoing research and reading
•   Ensure familiarity to relevant sales documents e.g. Incentive Forecast Document
•   Provide regular and ongoing feedback to the sales and marketing managers regarding:
•   Competitor activities and relevant market dynamics

Strategy and promotional messages and material

Business Area Management:

•   Create, build and expand the value of the business area through providing feedback of in-field intelligence.
•   Develop and expand technical knowledge necessary for business area management and customer interaction utilizing platforms provided by J&J
•   Ensures all requests and assignments meet company requirements and are submitted by established deadlines.

Positively Contribute Towards A High Performing Team Through Teamwork:

•   Develop a full understanding of business and team sales goals including brand specific critical success factors and participate in team discussions.
•   Build a collaborative environment across all teams and take on delegated responsibilities from NFSM to support the team as required.
•   Prepare, attend and actively participate in sales and marketing team meetings including weekly team meetings, trainings, congresses and cycle meetings.
•   Collaborate within and outside of the direct team to aid in delivery of business results.
•   Respond to requests for support from other customer facing colleagues in direct team or other regional divisional teams and proactively share information and insights.
•   Help to build respect, commitment, cohesion, responsibility and accountability within the team and work to building the Leadership Imperatives of Shape, Connect and Grow

Qualifications

• We’d love to hear from YOU, if you have:
•   Bachelor’s degree or equivalent tertiary qualification
•   Minimum 3-5 years sales experience in the pharmaceutical industry
•   Specialist physician detailing experience
•   Product & disease knowledge (Rheumatology / Dermatology) will be advantageous.
•   Ability to travel.

  Key competencies

•   Accountability and ownership
•   Proven leadership skills and ability
•   Excellent interpersonal and communication skills
•   Highly motivated and self-starter
•   Ability to work independently and be a team player.
•   Business acumen and ability to analyse data.
•   Able to plan and network effectively.
•   Exceptional selling ability and demonstrated successes.
•   Adaptable, flexible
•   Innovative and solution and decision seeking
•   High learning agility
•   Computer literacy
•   Territory management using supporting tools e.g., CRM platforms.
•   Valid driver’s license and safe driving record