Latest Vacancies at Johnson & Johnson

DESCRIPTION

The role will represent the Ethicon Franchise within the in the public sector by selling and/or promoting the Ethicon products and will be working alongside an appointed third-party intermediary to further leverage existing contacts within the Public Sector Procurement departments, to open doors and create business opportunities for Ethicon.

Key Responsibilities

• Pro-actively drive sales activities in the public sector to achieve set sales targets 
• Be able to lead key customer activities by demonstrating strong clinical/ product knowledge capabilities. 
• To promote and execute communicated strategies as determined by the marketing managers across different product portfolios. 
• Establish relationships with key stakeholders in the public sector market and create continuous, engagement platforms for marketing managers to drive strategic engagements with relevant KOL’s. 
• Create a clear and effective territory plan with customer & account segmentation according to sales opportunities and marketing priorities. 
• Be prompt and efficient in responding to customer needs and providing professional sales service. 
• Regular feedback and reporting on field activities, sales target achievement, forecasting and opportunities company provided sale force reporting tool. 
• Continuously sieve through sales and market data to be able to extract relevant market information to drive commercial activities. 
• Be part of all public sector collaboration teams and advocate for Ethicon product strategy implementation.
• Participate in relevant product trainings, marketing tools training and complete required assessments where applicable to establish proficiency. Maintain and continuously improve a sustainable compliance program (i.e. HCC/HCBI/Anti-Corruption/Privacy/HR-/Work instruction- & Quality policies).
• 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.
• Ensure optimal product knowledge in order to advise customers and detail products appropriately (achieve a minimum of 90% on all training tests).

QUALIFICATIONS

Required Skill

• Proven sales success within the medical environment
• Ability to work under pressure and be target driven
• Self -starter and highly self-motivated individual who can achieve desired results in a slow-paced public sector setting.
• Working knowledge of Theatre protocol pre- requisite
• Can work independently with a sense of individual drive.
• Ability to create network with key stakeholders at different level.
• Team player with strong interpersonal & communication skills
• High learning agility

Qualifications

• BSc degree or equivalent tertiary qualification
• 5- 10 years of selling experience in the medical industry, preferably surgical.
• Proficiency in computer skills
• Valid driver’s license
• When appointing potential candidates in South Africa, the Employment Equity and Broad-Based Black Economic Empowerment Legislation will be considered.

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Summary

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
• Regulatory Compliance

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.

Other features:

• 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

QUALIFICATIONS

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

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Key Responsibilities are:

• Responsible for supporting the development & execution of Biosurgery marketing strategy in close partnership with Ethicon Marketing leads, Sales Managers and Functional Business Partners (Governmental Affairs, Communication, Prof Ed, Commercial Ed, HE&R, Finance/Analytics, Pricing, Regulatory, Supply Chain and Quality).
• Develop and implement compliant pricing strategies – through portfolio positioning and market segmentation.
• Launch new products through a structured roll out plan involving commercial, education and tailormade marketing activities.
• Establish competitive product and market insights. Utilise market intelligence to ensure appropriate strategies and tactics are implemented.
• Generate accurate prognosis and manage stock levels in collaboration with the Deliver team to ensure optimal distribution into the market.
• Implement Product Training programmes together with Commercial Education to achieve the desired level of product expertise within the sales force.

QUALIFICATIONS

• Minimum 4 years of meaningful experience in marketing and/or sales in the medical device industry or pharmaceutical industry.
• Strategic problem solver with marketing skills and experience in translating strategy into tactical marketing/selling plans.
• Experience in leading/mentoring multi-functional teams or projects, successfully delivering objectives to time and within budget.
• Use and integrate the information from Marketing, SFE, Commercial, HE, Market Intelligence into a relevant plan of activities.
• Adept at problem solving supported by strong analytical abilities to make fact-based conclusions about the impact of market dynamics, customers, and competitors on marketing/selling plans.
• Effective communicator with proven experience in mentoring a sales team.
• Market development or value/demand creation through experience with customer and market insights or through experience in marketing or other critical functions.
• Proven track record of strong business results both in growth and market share gain.
• Agile at making things happen through managing relationships and networks effectively, both internally and with key external stakeholders.
• Demonstrates Credo based leadership principles in all interactions with internal and external stakeholders.

Preferred:

• Master’s degree or equivalent
• Experience in digital/omnichannel marketing
• Commercial Education/Training experience a plus
• Experience in Theatre environment

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Tasks & Responsibilities:

• Providing experienced legal advisory services to Janssen Pharmaceutical Pty Ltd in South Africa and handling company secretarial/corporate governance compliance in respect of the local board.
• Regional responsibility supporting the business in Sub-Saharan Africa (SSA), In this respect, the candidate will be working in close coordination with the Legal Director of the broader cluster of NEMA, which includes SSA countries.
• Providing strategic corporate counsel and efficient prevention or resolution of all legal issues relating to a wide range of legal fields, including corporate law, regulatory compliance, corporate and commercial transactions, special projects, contractual drafting and interpretation, trade law, employment, advertising, IP, and competition law. For example:
• Draft, review, vet and negotiate a variety of contracts with third parties, ensuring alignment with policies and applicable laws.
• Assess legal and commercial implications of contracts and advise on any risks that must be addressed and ensure effective management of legal and contractual risks.
• Deployment of policies and procedures that are aligned with business strategic imperatives.
• Lead and co-ordinate various company activities and ensure compliance with company standards and corporate governance.
• Advising on compliance with international anti-corruption regulation, in particular FCPA legislation, acting as the legal “touch-point” for these matters.
• Collaborate with internal partners to assess legal risks and develop strategies to minimize them and resolve disputes efficiently.
• Coordinate and run dispute resolution and litigations (working closely with external counsel as necessary).
• Stay abreast of relevant laws and regulations affecting J&J 's operations and develop and implement compliance programs to ensure adherence to legal requirements.
• Conduct training sessions for employees on legal matters and compliance issues.
• Successfully collaborate with and coordinate external legal counsels.
• Actively participate in the external environment with key trade associations.

QUALIFICATIONS

• Law Degree from a reputable institution.
• Admitted Attorney with 7-10 years post-qualification experience.
• Ability to provide support as in-house counsel in a sophisticated and sizeable organization and/ or as attorney in a law firm, where the candidate was used to being directly exposed to local and international clients.
• Knowledge and experience of the Foreign Corrupt Practices Act (FCPA).
• Ability to be self-motivated, to work autonomously and effectively partner with various business partners and functions across all levels of the organization -effective time and management skills are important-.
• Ability to deal well with ambiguity and demonstrate strong organizational, process and interpersonal skills (including a high degree of emotional intelligence and an ability to influence outcomes in a productive manner as necessary).
• Strong technical legal ability and highly organized and detail oriented.
• Litigation experience is preferable but not crucial.