GlaxoSmithKline (China)

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GSK are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.

We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.

Research is vitally important to the success of our business, and we spent £3.4 billion in 2013 in our search to develop new medicines, vaccines and innovative consumer products. We are one of the few healthcare companies researching medicines and vaccines for the World Health Organization’s three priority diseases - HIV/AIDS, tuberculosis and malaria.

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MA Manager/ Senior MA Manager

Location: Shanghai, china

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GlaxoSmithKline (China)

6/F The Headquarters Building
Tibet Road (M)
Shanghai ,200001

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MA Manager/ Senior MA Manager

(CHINA) and various
Job Reference:
Functional Area/Experience:
Business, Accounting & Finance / 2 Years
Job Description:

Job Description & Qualifications

Your Responsibilities: 
Role Purpose :

• Work closely with local taskforce (including sales, DO) team to ensure GSK business operation. 
• Take responsibility of local government affairs to support regional growth by local pricing /reimbursement/EDL and government related support. 
• Educate and update key hospital decision makers (including directors and pharmacy heads) with healthcare policies, hospital management, disease burden and treatment, and GSK product knowledge to ensure hospital decision-makers have adequate knowledge to list GSK products in each hospital and patients can access GSK medicines.   

Key Accountabilities/Responsibilities 
1. Stakeholder Management: Build up and maintain stakeholder relationship/and management with local governments/hospitals.
2. Market Access
2.1. Work closely with local taskforce (including sales, DO) team to maximize market access opportunity including preparation of local RDL updates, provincial/city reimbursement database, outpatient subsidiary drug listing.
2.2. Drive and coordinate cross functions for provincial major disease negotiation and explore innovative reimbursement access opportunities at local level. 
2.3. Drive and coordinate on GPO. Work closely with local taskforce (including sales, DO) for hospital price re-negotiation followed SOP.
2.4. Work closely with CD team and support provincial bidding activities.
2.5. Be responsible to hospital listing in MA targeted hospitals with cooperation across local taskforce (including sales, DO).
2.6. Alert higSh risk delisting to ensure safety operation in target hospitals.
2.7. Monitor and get deep understanding of policy/regulation issued by local authority from DRS, anti-trust, pricing behavior supervision, low price drug list perspectives to deliver and coordinate related resources.
2.8. Collect and update local data and policies relative to pricing/ reimbursement/ bidding and so on. 
3. Activity Management: Design, develop and coordinate provincial projects to build up platforms.




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Area Lead Safety Point of Contact

(CHINA) and various
Job Reference:
Functional Area/Experience:
Business, Accounting & Finance / 3 Years
Job Description:

Job Description & Qualifications

Your Responsibilities: 
The purpose of this role is to support delivery of pharmacovigilance in CH China, Hong Kong and Taiwan Local Operating Companies. The Area SPoC role is LOC cost and HC to report locally & operationally to CH Area Medical Lead with dotted line to CH Head of Safety/Affiliate Liaison.

The person will be located at Area level with acceptable change of location to the most PV needed country within the Area (depending on local regulation requirements).

The role will regularly liaise with Pharma NSCs, PRPs and relevant stakeholders (i.e.Business leads) to ensure PV related activities, periodic meetings and reports are submitted in a timely manner and with the required quality.

The Role supports GMs, Area Medical Lead and CH Head of Safety to ensure delivery of  Pharmacovigilance as per PV SSAs in all countries in the corresponding area. The Area CH Safety PoC will ensure compliance with the PV SSA which includes but is not limited to:  

• Lead annual review and update of all PV SSAs of the corresponding area and facilitate the management of the PV SSA with Pharma. 
• Update the CH General Managers and CH Head of Drug Safety or delegate on the status of the LOC PV system (e.g., Quarterly Pharmacovigilance reports (QPV report)), expedite notification of any PV issue(s) that may impact the CH business, and provide periodic reports on activities covered on the PV SSA for each GM in the Area.
• Lead regular meetings with the NSC to ensure activities are being conducted as per agreement.
• Support GMs and Area Medical Lead in the PV SSA negotiation and renewal.

• Working as part of the Area Medical Affairs team and Central Safety in development of a Culture of High Performance and quality.
Safety/Compliance  implementation
• Perform an annual review of the PV SSAs  (or more frequently if required) with the corresponding  NSC and request a new version is signed off by the GMs and agreed with appropriate staff, even when there has been no change.
• Ensure that the PV activities retained by CH under the PV SSA have been discussed and agreed with the CH responsible person executing the activity, the CH Head of Safety or delegate and the CH Area Lead. 
• Define the list of local Journals for AE monitoring for CH products. Communicate the list with Pharma and ensure monitoring of these journals for AEs.
• Agree with the NSC the corrective actions and owners to mitigate PV risks identified from different sources (e.g., risk assessment questionnaires, Management Monitoring, Independent Business Monitoring and/or Independent  Assurance).
• Promptly inform the NSCs of any deviations, issues or risks identified for the PV activities retained by CH.
• Liaise with different business owners to ensure appropriate implementation of relevant processes that impact PV tasks as covered in the PV SSA: 
o Handling of Product Complaints
o Medical Information (Ensure Medical Information process captures PV requirements as per SOP-CHC-409)
o Interative Digital Media, Market Research, Patient Support Programs (ChimAERa) 
o Handling third party deals as per  SOP- GSKF- 012  
• Ensure all required CH reports (such as quality complaint sheet, Medical Information log, etc) required for AE reconciliations executed by the NSC  are submitted to the NSC as per the planned schedule. Support the NSCs when issues are identified in this process.
• Support NSC for audits on Consumer Healthcare business and data collection for internal and external inspections.
• Ensure compliance of Regulatory responsibilities for safety-related activities such as: 
• Support in collecting PSUR/PBRER related sales data and safety action in timely manner on country level unless this is agreed to be managed by NSC.
• Ensure an updated list of Consumer Healthcare products covered by this agreement, including the local acquisitions.  
• Ensure appropriate implementation of label changes. 
• Update PRP/NSC on country specific PIRC/LIC and safety related action.
• Sending periodic reports (e.g.  PBRERS) to the local regulatory authority on country level (in some countries as applicable) unless this is agreed to be managed by NSC or Regulatory.
• Ensuring there is a process to keep the product label updated for products with no PV central support.
• Identify the local Products with no PV central support and alert central safety and Area Medical Leads for the needed safety actions such as signal detection process, PSURs or any other local safety report required by local regulations.
• Manage DHCP letter process in CH LOC. 
• Manage oversight of Risk Management Plan process and implementing in the LOC. 
• Support NSC and/or HR to ensure implementation of PV training for new starters. 




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Senior Medical Affairs Manager

(CHINA) and various
Job Reference:
Functional Area/Experience:
Business, Accounting & Finance / 4 Years +
Job Description:

Job Description & Qualifications

Your Responsibilities: 
The purpose of this role is to support the delivery of medical excellence and if required leadership within the regional CDMA organization in order to deliver business results and ensure effective deployment of Medical Governance framework across GSKCH business.

This position will support the Regional Medical Affairs lead in driving the efficiency and effectiveness of the CDMA Community, plus ensuring that collaboration with the various business functions that rely on the CDMA functions to drive and implement product strategies including Global Category Leads, Regional Commercial Leads, Regional Commercial Operations Directors and GM’s, Safety, Legal, Corporate Compliance functions is performing optimally.

This role is a single contribution role as part of specific local clusters, based in a strategic locations and will have accountability for- and oversight of the following activities with the added complexity of multiple Regions and stakeholders, cultures, different LOCs, Category Medical teams with complex governance and business expectations:

• Enhancing Global Medical Community Operating Model to drive results for GSK CH 
• Implementation of process improvement plans to enhance organizational efficiency and continuous improvement.  
o Supporting delivery of KPIs to measure success / improvement areas
• Supporting the Regional MA lead or Regional/ Country Medical Affairs Principal Scientist in delivering the annual goals and objectives activities 
• With oversight from Regional MA lead or Regional/ Country Medical Affairs Principal Scientist drive medical communication and publication strategy across all Categories
• At a regional project specific level drive execution timelines and support budget management
• Key contributor to the Regional MA Team
• Implementation of scientific engagement activities
• May act as an interface on behalf of GSK with external organizations including Health Authorities, Healthcare Organizations, External Experts etc 
• With oversight from Regional / Area MA lead or Regional/ Country Medical Affairs Principal Scientist support Medical Affairs activities including but not restricted to:
o Input on medical concepts, ethics and consumers safety and well-being, 
o Development of accurate, technically supported and  business oriented claims
o Medical input to data collection and analysis of GSK products and competitors 
o Review and evaluation medical approval of promotional materials 

These activities will involve building networks with and working closely with representatives from cross-functional teams within Regions and LOCs.

Key Responsibilites: 
• With oversight from Regional MA lead or Regional/ Country Medical Affairs Principal Scientist lead provide medical input to REGION regulatory applications, new product development and clinical activities, and business development and acquisition initiatives
• Provide medical and technical training of REGION LOCs about GSK products and competitors
• Act as GSK medical voice in all interactions with consumers, physicians, medical societies, institutions and government bodies. Includes not limited to:
o To medically support customer enquiry systems which respond to enquiries and complaints
o Medical input to answer consumers relations questions and complaints as required
o Working with the medical information department to evaluate consumer contacts to identify trends and product’s opportunities/ weaknesses  
o Oversight of Medical Information at the LOC , including Collecting, analyzing and communicating medical information trends to regulatory, medical, sales, marketing and commercial functions, enabling trend identification complying with all relevant regulations and professional standards  
• Promoting the safe use of all GSK products in REGION by ensuring all Pharmacovigilance systems are in place in LOCs in compliance with relevant laws and internal policies, fulfil tasks of Consumer Health Safety Point of Contact
• Partner with Pharmacovigilance team in order to ensure that GSK activities are conducted in accordance with applicable law and Company policies
• With oversight from Regional / Area MA lead or Regional/ Country Medical Affairs Principal Scientist responsible for medical activities including but not restricted to:
o Development and medical approval of accurate, technically supported and  business oriented claims
o Support to market information on data collection and analysis of GSK products and competitors 
o Coordinating evaluation of promotional materials