Overall, Purpose of this Job:
This professional will be responsible for performing activities within the assigned country/countries that ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, also ensuring that clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.
The responsibilities & the impact You will have:
Quality and Compliance Oversight Activities:
- Monitor compliance risk and ensure mitigation/remediation actions are Defined.
- Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:
- Conduct On-Site Compliance Monitoring Visits.
- Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial.
- Planning and execution of local QC checks.
- Support and advise local and central study teams in root cause analysis of significant observations.
- Ensure appropriate filing of the QC reports.
- Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
- Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed.
- Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.
- Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents.
Local Onboarding and Consultation:
- Support onboarding of new hires.
- Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc.
- Provide advice regarding SOP, system and GCP questions of moderate complexity.
- Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
Local regulatory intelligence:
- Perform impact assessments of new/revised local regulations, guidance and standards.
- Support central functions in ensuring local intelligence is up to date (e.g., RIACS,T-Race, IRON).
Collaboration with Business Quality:
- Support LOC Management Review in collaboration with LOC Business Quality partners.
- Support local supplier assessments as appropriate.
- Support annual Due Diligence update, certification and training of local suppliers, if applicable.
We’d love to hear from YOU, if you have:
- A minimum of a Bachelor’s Degree in Science (BSc)or equivalent diploma.
- A minimum of at least 4-6 years relevant experience in Pharmaceutical Industry experience is required, with GxP experience within clinical research and development and/or quality assurance.
- Knowledge of the overall drug development process.
- Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities).
- Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
- Ability to translate data into information and strategies into executable action plans improving the business.
- Ability to motivate professional colleagues and stakeholders.
- Conflict resolution/management and negotiation skills.
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
- Experience of the key customers’ business processes and practices.
- Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
- Experience with regulatory submissions (NDA, BLA) is an asset.
- Proficient in Microsoft Office applications.
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To increase the sales of Ethicon products in a concise, effective manner in accordance with company policy and strategies. Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your leadership experience, express your passion, and touch the world.
- Achievement of territory sales forecast.
- To grow our sales faster than our competitors and to gain market share.
- Developing sustainable and long-term relationships with our customers.
- Maintain and continuously improve a sustainable compliance program (i.e., HCC/HCBI/Anti-Corruption/Privacy/HR-/Work instruction- & Quality policies).
- Establish specific sales objectives/plans per account aligned with national sales and marketing strategies.
- Ensure optimal product knowledge in order to advise customers and detail products appropriately (achieve a minimum of 90% on all training tests).
- Maintain all equipment / company assets / records in good working order and ensure accurate record keeping of same e.g., laptop, cell phone, equipment / generators etc.
- Be presentable and cultivate a positive image of Johnson & Johnson Medical at all times.
- Collaborating with all internal stakeholders to improve selling and planning skills.
- Willingness to travel when needed to other regions.
- Relevant BA/BS degree required.
Experience And Skills:
- At least 3 – 5 years previous sales experience with a medical background with achievement of sales targets
- Working knowledge of the private sector for medical devices
- Working knowledge of Theatre protocol pre- requisite
- Effective communicator with experience in presenting complex marketing, clinical and non-clinical issues to Senior management and stakeholders
- Experience in working with and presenting marketing and product issues to Management
- A self-starter who is agile at making things happens
- Collaborative attitude across organization
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To effectively complete all required Regulatory tasks relating to product registrations and dossier lifecycle maintenance for products the local operating company (LOC) has regulatory responsibility and to ensure these tasks are performed in line with the local, regional legislation and Global Regulatory Affairs (GRA) EMEA/local strategy and directives. Countries covered include South Africa and Sub-Sahara Africa countries.
The main duties and responsibilities of the position are:
Applications for registration
- New regulatory submissions (NCE; Line extensions, etc.)
- Clinical submissions (new indications)
- Other: responding to resolutions (clinical/pharmaceutical)
- Regulatory Renewals (as applicable)
- Compiling and submitting applications for registrations (human products), in the eCTD/CTD (eSubmission) format, to the Health Authority (HA).
- Liaising with GRA for all outstanding information and samples required for successful product submission.
- Responding to all Clinical; Pharmaceutical & Analytical recommendations from the HA.
- Payment of any HA related registration/application/variation & retention fee.
- Notifying GRA of submission, interim HA communications and approval dates as well as maintaining the local Regulatory Database and Global electronic platforms (tracking systems).
- Internal stakeholder notification of Registration approvals/product discontinuations.
- Collaborating with marketing (local CVT) to ensure product launch readiness and advising them of any developments thus enabling the CVT to optimize the strategy
- Type I/II variations
- Conversion to eCTD/eSubmission format
- Other (respond to HA letters, QA queries, exemption requests and renewals)
- Development and Maintenance of Labeling Documents in line with local regulatory (legislative) requirements and Global Regulatory Affairs (GRA).
- Maintenance of the regulatory dossiers post-registration in terms of pharm-chem (CMC) and other required variations.
- Notifying GRA of submission, interim Health Authority communication and approval dates as well as maintaining the local Regulatory Database and Global electronic platforms.
- Coordinating the approval and superseding of regulatory documents in response to Regulatory Affairs authority letters/approvals.
- Submission of exemption requests to HA (labeling, once off batch, post-importation testing etc.)
Regulatory Compliance (Safety)
- Safety reporting
- HCC compliance
- Inspection readiness
- Implementation of safety amendments requested by the local Health Authorities and liaising with GRA on such issues.
- Coordinating and submitting notifications and/or responses to the Health Authority following a request for additional safety information in line with local/GRA procedures.
- Receipt, response, tracking of HA queries including Dear Healthcare Professional letters.
- Maintenance of all related regulatory databases and electronic (tracking) platforms both local and regional.
- Ensuring safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
- Ensuring HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors
- Ensuring inspection readiness with respect to personal training compliance, and availability of a recent CV and individualized Job Description
Other Regulatory Activities
- Advertising (promotional) review and approval
- Printed components
- initiation (R4AW), proof reading & final approval of all product-related printed components
- Review & regulatory approval of allocated promotional & training material within the allocated 24-hour turn-around time.
- Ensure all promotional and educational material is compliant with the Regulatory dossier (approved label), relevant Acts, Code of Marketing Practice; and GRA requirements and to confer with Medical Affairs/Marketing in this regard.
- Regulatory support to product managers in all matters pertaining to Regulatory.
- The local initiation (R4AW) and final approval of all printed components artworks (& text changes) for products the LOC has Regulatory responsibility.
- Team collaboration and discussions about new guidelines, SOP's, sharing learning experiences and best practices
- Internal pre-submission quality reviews are completed for other RA experts before submission
We’d love to hear from YOU, if you have:
- B. Pharm. or Dip Pharm qualification.
- Registration with the South African Pharmacy Council
- Computer Literacy
- Excellent written and verbal communication skills
- Strong communication skills with key customers both internal and external (e.g. Global Regulatory Affairs, Marketing and MCC)
- Meticulous, accurate and a high level of attention to detail
- Ability to work independently in a highly pressurized environment.
- Self-starter, ability to multi-task and prioritize.
Core competencies required for this role:
- Knowledge of legislative requirements (Guidelines, The Medicines Act and Regulations).
- Knowledge of Foreign Registration Requirement (viz. Africa)
- Understanding of the Code of Marketing Practice
- Knowledge of international requirements.
- Understanding of departmental and company SOP’s.
- Proficient in Lotus Notes.
- Analytical and detail orientated.
- Planning and organization
- Teamwork and co-operation