Head of Medical, China (Pain Management)
Location: China (Shanghai/Beijing)
About the Business
Our client is a leading provider in China's
pain management
market. For over 30 years, it has introduced
innovative opioid analgesics and novel generic pharmaceutical products,
helping to improve access to modern pain relief for patients across China.
Role Overview
Provide medical professional support for the company and its products, communicate medical information, define the medical positioning of products, organise medical activities, act as a bridge between R&D and marketing, and ensure the management of the entire lifecycle of medicines.
Qualification/Requirements
- Education
: PhD in Clinical Medicine, Anesethetist or related fields; - Solid foundation in medical theory, including specialised
knowledge
in areas such as
Narcotics and Anaesthetist
; - Experience and Skills
: Over 10 years of clinical project experience; familiar with full IVD/CRO product registration processes and GCP regulations; - Complete product registration experience
; understanding of domestic and international clinical research trends and policies.
Core Competencies
- Strategic Planning: Develop and implement medical strategies;
- Team Management: Lead medical teams to collaborate efficiently;
- Communication and Coordination: Maintain relationships with KOLs (Key Opinion Leaders) and partners.
Key Responsibilities
Medical-related Duties
Responsible for providing medical support in all stages of drug development, registration, production, and sales;
Responsible for collecting, organising, and archiving medical information to provide decision-making support for the company;
Responsible for communication and collaboration with government departments, industry associations, and academic organisations;
Responsible for maintaining and managing Key Opinion Leaders (KOLs);
Responsible for organising and arranging medical academic meetings related to the products;
Responsible for maintaining registered products, supporting and managing re-registered products, and planning strategies for new product registration;
Responsible for medical training and education for team members, relevant internal staff, sales personnel, doctors, nurses, and patients;
Responsible for handling customer complaints, providing medical consultation, and ensuring customer satisfaction;
Responsible for conducting clinical research before and after the drug launch;
Responsible for organising and implementing on-site inspections for registration, including research sites, production sites, and clinical trial data verification;
Responsible for organising non-clinical drug research, including pharmacodynamics, pharmacokinetics, toxicology, and formulation development.
New Product Development and Registration
New Product Development Responsibilities
Ensure that the content of new product development meets the requirements for registration applications and complies with relevant laws and regulations
Ensure that testing methods developed by pharmaceutical R&D institutions comply with relevant regulations and are applicable, and manage responsibilities related to new product registration testing (sampling, submission for testing, monitoring, etc.)
Handle tasks related to the transfer of analytical methods between R&D institutions
Ensure work is carried out according to relevant plans before the launch of new products
Conduct post-marketing change research and prepare submission materials
Review clinical trial protocols, ensuring clinical trial reports meet the requirements for registration applications and comply with relevant laws and regulations
Ensure that the production processes of new products (including formulations and packaging, process procedures, quality standards, batch records, process validation, product co-line risk assessment, critical process parameters and quality attribute risk assessment, etc.) comply with relevant laws and regulations and are applicable
Optimise production processes for marketed products
Special Drug Management Responsibilities
Handle applications for "Narcotic and Psychotropic Drug Transportation Certificates" and "Narcotic and Psychotropic Drug Purchase Certificates"
Manage matters related to special drugs during new product development
Manage pharmacovigilance tasks during new product development
Development and Registration of Pharmaceutical Products
Product Research: Domestic listing of domestic and imported products; disclosure of reference formulations; consistency evaluation; clinical research; registration filing, etc.
Project Application: Prepare project application materials in accordance with the regulations of relevant national authorities, track the application process until approval is obtained; maintain approvals after project establishment
Product Development: During product development, communicate with third-party companies, regulatory agencies, and relevant internal departments, coordinate project progress, resolve issues arising at each stage; record handover of external materials and documents
Clinical Research: Communicate with partnering third-party companies, prepare required products, reference materials, documents, etc. for clinical research as required, and track the progress of clinical research until completion
Product Submission: Submit application materials in accordance with the formats required by the relevant national authorities, track receipt, correction, and acceptance; respond to notices regarding registration inspection and on-site verification, coordinate registration inspections and on-site verifications; prepare and submit supplementary documents as required following notifications, and track communication with the review departments until approval is obtained; product re-registration applications
Active Pharmaceutical Ingredient (API) Registration: According to company plans, prepare API registration materials in accordance with national regulatory requirements and submit applications, track subsequent receipt, corrections, acceptance, registration inspections, supplementary materials, and complete necessary tasks until registration is publicly announced
Drug Import: In line with national regulatory requirements and company needs, complete applications for special drug import permits, reference preparations/control materials permits, or one-time import applications
Departmental registration-related training, document management, etc.
Responsibilities for Special Drug Management
Responsible for applications for special drug import permits
Provide pharmaceutical professional support regarding special drugs, including answering pharmaceutical-related questions and assisting in interpreting pharmaceutical data
Define key information for special drugs, including disease areas, target populations, and therapeutic advantages, providing important reference for product R&D, production, and promotion
Monitor safety issues related to the use of special drugs during clinical trials
Pharmacovigilance-related Responsibilities
Responsible for organising the establishment of the company's pharmacovigilance management system and implementing related activities
Responsible for organising pharmacovigilance activities across the stages of drug research, registration, production, and marketing
Responsible for collecting, managing, and reporting suspected adverse drug reaction information
Responsible for identifying and assessing drug risks, providing risk management recommendations, and organising risk control and risk communication activities
Responsible for preparing core pharmacovigilance system documents, periodic safety update reports, and pharmacovigilance plans
Responsible for organising post-marketing drug safety studies
Responsible for organising or coordinating pharmacovigilance-related communication, education, and training activities
Other tasks related to pharmacovigilance
Marketing
- Responsible for preparing, reviewing, and controlling the company's marketing and academic promotion budgets, ensuring the rational and effective use of funds for various marketing activities
Others
Responsible for interdepartmental collaboration within the company to promote new product development and launch, ensuring market needs are responded to in a timely manner;
Responsible for compiling product manuals and providing product knowledge training;
Participates in product recall-related work;
Responsible for forming the medical team (including medical, new product development, regulatory, and pharmacovigilance), establishing and managing departmental functional areas, staff training, performance evaluation, internal department collaboration, and cross-departmental cooperation within the company
Responsible for establishing medical management systems and overseeing their implementation;
Complete other tasks assigned by company leadership.