上海招聘

Location: Shanghai,China
Job Description
Position Title
Hub Labeling Manager (HLM)
Reporting to Medical Director;
Number of New Hires:
--Two native Chinese who are fluent in Korean and meet the criteria mentioned below. And have a pipeline of another 2-3.
Division/Organization
Medical / Worldwide Safety & Regulatory Operations (WSRO)
Line (i.e., Technology Infrastructure)
Medical Documentation & Labeling (MDL)
Department (i.e., Application Hosting Services)
Global Labeling Management
Position Purpose
The Hub Labeling manager (HLM) is responsible for executing the content management of local product documents (LPDs) regardless of registration procedure including USPIs and Centralized Procedure SmPCs for their assigned products across multiple countries/regions.
This role will keep up to date with regional labeling regulations. Additionally the role will oversee content across all labels for their assigned products in their assigned regions and drive consistency of content and messaging wherever possible.
This role will focus on and be responsible for the production of labels referred to as LPDs, the associated Local Language Documents (LLDs); any Patient Information Leaflets (PILs) and any Technical leaflets regardless of registration status/procedure across the globe. HLMs across the regional areas will work together to ensure that labeling is updated on a timely basis according to internal SOPs and external regulatory requirements. Where appropriate, the HLM will seek advice from identified roles when authoring text that deviates from the core.
This role will interface with Global Labeling Leads, PCO colleagues, MDL Authors, Global/Regional Medical Therapy Area (TA) Leads, Submissions Specialists and Global Labeling Operations Specialists in the delivery and management of labeling text through appropriate processes and systems to assure the timely submission and ultimate approval of product labeling.
This role will act as a Subject Matter Expert (SME) on regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence. Additionally this role will support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries
Primary Responsibilities
This position reports to the locally based Global Labeling Management Team Lead.
Utilize regulatory expertise to review, develop and deliver core labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
Engaged in necessary labeling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs,CRP-SmPCs and MRP/DCP-SmPCs as necessary
Employ a consistent approach to the content of labeling documents assuring that governing SOPs and IGs are followed and external regulations are met.
Ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
Communicate, plan, prioritize and deliver submission documents according to company targets and submission requirements; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience
Ensure all actions taken within role follow applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. Champion and/or participate in continuous improvement efforts related to business practices and tools utilized within role.
For deliverables in scope, support responses to inquiries from colleagues in response to inspection activities and regulatory agency questions.
Technical Skill Requirements
. Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling especially
clinical submissions and demonstrated ability to decipher and understand implications of label changes both pending, approved and historical across document types and geographical regions/countries
. Demonstrated ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation
. Fluency in English language important however multi-language skills are advantageous
. Written and verbal communications clear and effective
Resources Managed (budget and FTEs)
. No direct reports; individual contributor role
Qualifications (i.e., preferred education, experience, attributes)
Education:
. Medical ,pharmacy and life science graduate;
. Advanced academic qualifications/degree such as PhD an advantage but not essential
Experience:
. Significant 'hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment). Experience at the country level important and advantageous especially with the perspective of the implications of a CDS on LPDs
. Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.
. Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages
. Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
. Understanding of regulatory authority philosophy and expectations
. Knowledge of global/regional regulatory guidelines and requirements important
. Knowledge of Clinical Variations preferred
. Excellent written and verbal communication skills essential
. Complete Fluency in English Language
. Proven strength in logical, analytical and writing ability essential
. Readability Testing knowledge an advantage but not essential
. Demonstrated project management skills and attention to detail required
. Proven ability to negotiate, influence and problem solve
Core Competencies (list 3-5 competencies only, see Competency Framework for references
Acts Decisively: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; Able to make a quick decision; Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; Most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; Sought out by others for advice and solutions.
Seizes Accountability: Will stand up and be counted; Doesn't shirk personal responsibility; Can be counted on when times are tough; Willing to be the only champion for an idea or position; Is comfortable working alone on a tough assignment; Can be counted on to exceed goals successfully; Is constantly and consistently one of the top performers; Very bottom-line oriented; Steadfastly pushes self and others for results.
Commits to the Company Values: Communicates a compelling and inspired vision or sense of core purpose; Talks beyond today; Talks about possibilities; Is optimistic; Creates mileposts and symbols to rally support behind the vision; Makes the vision sharable by everyone; Is aligned with the culture, values and mission; Can inspire and motivate entire units or organizations; Operates with the mission and values in mind; Encourages others to act in a manner aligned with organizational culture, values and mission.
Change Agile: Can effectively cope with change; Can shift gears comfortably; Can decide and act without having the total picture; Isn't upset when things are up in the air; Doesn't have to finish things before moving on; Can comfortably handle risk and uncertainty; Good at figuring out the processes necessary to get things done; Knows how to organize people and activities; Understands how to separate and combine tasks into efficient work flow.
Peer Relationships: Can quickly find common ground and solve problems for the good of all; Can represent his/her own interests and yet be fair to other groups; Can solve problems with peers with a minimum of noise; Is seen as a team player and is cooperative; Easily gains trust and support of peers; Encourages collaboration; Can be candid with peers.
Pfizer
Type:
Full-time
Experience:
Mid-Senior level
Functions:
Research
Industries:
Pharmaceuticals

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