Experienced Labeling Specialist, Labeling Group, License

4週間前

Chiyoda myGwork - LGBTQ+ Business Community

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.

Please do not contact the recruiter directly.

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

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Product Submissions and Registration

Job Category

Professional


All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description


JOBSUMMARY
Underthesupervisionoftheir Supervisor

DevelopJapanesepackageinserts(JapanesePI)basedonJapanesetarget label
RunJapanLabelingcommitteeprocesstodeveloplabelingpositionsformarketedproduct issues
CollaboratewithGlobalLabelingand/orCDToncreation/revisionofJapanesePI proactively
Maintain someJapanesePIinpost-approvalenvironmentand negotiateJapaneselabelingofMarketedproducts with HA

Keyresponsibilities

DevelopmentJ- PI

Participatesindevelopmentoflabeling negotiationJapanese strategiesanddevelopmentofsupporting documentation for Japanese labeling
DevelopJapanesePIfromJapaneseTarget Label
UpdateJapanesePIbasedonupdatedCCDSandnew data
InterfacewithtrackingfunctiontoensurethatchangesarebeingtrackedandadviseonJapaneselabel audit
RuntheJapanLabelingWorkingGroupprocessandparticipateinthese groups

Labeling Committee

Run JapanLabelingcommittee processto develop Japaneselabelingpositionsforboth development andmarketed productissues
ExplainlabelingpositiononproposedlabelingattheJapanLabeling Committee
PreparefinalproposedJapanesePIforreviewbyLabelingWorkingGroupandLabeling Committee

RelationshipwithGlobal Team

ServeasasupportmemberoftheglobalLabelingWorkingGroupandprovidesinput onproposed updatestothe CCDS/USPI/SmPC
ReceiveinformationonCCDSfromGlobalLabelinganddisseminateittorelevantpeopleinJANSSEN JAPAN
CommunicatewithGlobalLabelingand/orCDToncreation/revisionofJapanese PI
ShareinformationwithGlobalLabelingonUS/EU/Japanlabelingandactasawindowto it

ProvidesupportinpreparingresponsestoCallforInformation inpreparationofPSURsregardingJapaneseinput (Approval information:
Indication, Dosage and Administration etc).

Postapproval maintenance

Maintain Japanese PI in post-approval environment
Revise Japanese PI and provide input on implementation timelines as necessary
Provide labeling support necessary to defend the company labeling position in Japan when issues arise

Team with Japanese Labeling Therapeutic area representatives and collaborate with partners including Health Authorities, Manufacturing, Regulatory Operations, and Regulatory Affairs etc in Japan.

Interactions with HA

Negotiate Japanese labeling of post-approval products with HA (ensure alignment with global strategy) as appropriate
Review Japanese PI in preparation for meeting with Health Authorities

Print Labeling And Others

Execute the technical aspects of labeling process (e.g., partner with Japan Submission Operations to prepare labeling submissions, and with Graphic Services to develop artwork for implementation in packaging and website display)
Prepare Japan unique explanatory documents called "Kaisetsusho" which explains rationale for "Precautions for Use" included in new drugs' J-PI.
Ensure effective quality control of labels

Requirements

Experience/Knowledge

A minimum of 3 years of pharmaceutical industry experience (clinical development, safety, regulatoryaffaris) and/orexperienceassociatedwithproductlabeling/labelingregulationsis required.

Skills/Capabilities

GoodverbalandwrittencommunicationskillsinJapanese/Englishis required


TOEICscore:
over 700

Qualification/Certificate

Aminimum ofBachelordegreeinascientific discipline,especiallypharmaceuticalscience,is preferred.

Based on your experience and interview evaluation, the position title and level may vary.
If you are Japan employee, please read "Internal Application Guideline" in Ask GS.

Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR.

If you are Japan's employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the "Internal Referral Overview" on the Ask GS and you have made a compliant referral.

Required Skills


Preferred Skills:
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented
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