Johnson & Johnson (Hong Kong) Ltd 香港招聘

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Specialist, Regulatory Management Centre (RMC) Submission

Overall purpose of job

Develops skill set to enable value added individual contributions, who works under close supervision. Applies methods for planning, directing, coordinating and controlling regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations to ensure compliance with regulatory/ government standards.
Maintain regulatory compliance and system compliance.
Ensure training assignment is appropriate and timely.

Key responsibilities:

RMC submission

Assists by providing knowledge in implementing compliance with regulations to enable products that are developed, manufactured, or distributed meet regulatory agency requirements.
Applies functional analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
Contributes on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
Advises product development teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
Carries out the detailed regulatory submissions required for new and existing product approvals and registrations.
Coordinates Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits.
Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Regulatory Compliance

Archive regulatory documents, maintain or support regulatory compliance metrics and training metrics, monitor HK & MO NCE registration status and adopting regulatory requirement (ARR) compliance for external changes, renew product licences.

System Compliance

Manage regulatory documents or licences in systems, e.g. truVault, Corporate Entity Management System (CEMS)
Assign training according to LOC RA-related training matrix to other functions by SUMMIT Training System.

Required Qualification

University degree in pharmacy, life sciences or equivalent field.
3 years or more relevant work experience in Regulatory Affairs/ Government Affairs/ Quality/ Compliance/ Manufacturing in medical or pharmaceutical companies. Less work experience/ Fresh graduate maybe considered with title adjustment subject to work experience.
Experience of working in a virtual team and/or global organization.
Previous experience in RA role as Associate, Professional or similar role is of advantage.
Knowledge of local regulations and international standards.
Able to make independent decisions.
Able to analyze (complex) information and situations and to formulate clear solutions.
Constructive team player.
Good communication and collaboration skills are required

Required Core Competencies:

Project management skill
Detail-oriented skill & Holistic view
Analytical skill with technical RA knowledge
Adaptability on acquiring local knowledge and shift between local situations
Communication skill with cultural sensitivity in working with stakeholders across markets
Collaboration & Team player
Proficient in English (including technical RA English)

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Associate Key Account Manager - Immunology

Overall purpose of job:

Responsible for promoting our pharmaceutical products to the healthcare professionals with the aim to bring our innovative treatment solution to our patients and for mentoring junior sales representative or new comers.

Essential duties and responsibilities:

Develop strategic plan to achieve sales objectives and other qualitative objectives
Manage the call plan for both existing and new customers and manage the assigned territories
Make regular visits to identify customers’ needs and provide treatment solution to HCP
Analyze ordering pattern & product sales and prepare all the related reports and presentation as required.
Provide customer services to our HCP
Collaborate with other departments to achieve company objectives
Provide accurate sales forecast
Relay market insight to management.
Comply with Integrity and compliance standard
Mentor junior sales representative or new comers
Demonstrate as a role model in sales function

Special requirements:

Science background is preferred but not a must

Job locations: Hong Kong

Job Requirements

Essential knowledge and skills:

Bachelor’s degree or above
Minimum 4-year solid experience in selling & customer management in the healthcare industry
Demonstrate effective communication skills

Core competencies required for this role

Essential