Bilingual Scientific Reviewer - Janssen Inc. - Toronto, ON-2863141217
Description
At Janssen, weare dedicated to addressing and solving some of the most important unmetmedical needs of our time in oncology, immunology, neuroscience, infectiousdiseases and vaccines, metabolic and chronic diseases and women’s health.Driven by our commitment to patients, we bring innovative products, servicesand solutions to people throughout the world. Janssen Inc. is a member of theJanssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.cafor more information.
Position Overview
The BilingualScientific Reviewer will be reviewing French language scientific and labellingcontrolled materials in accordance with current procedure while ensuringaccuracy, timeliness and cost-effectiveness.
MAJOR RESPONSIBILITIES:
Review Frenchlanguage Labeling text and other controlled materials (promotional materials,adverse event reports, etc.) for Janssen Inc.
Give finalsign-off for release of French language Labelling and other controlleddocuments
Review / approve/ negotiate changes made to French copy by PAAB or other regulatory bodies
Translatetechnical/medical content such as AE reports and patient medical records, labreports, etc. (Drug Safety and Surveillance)
Audit andevaluate files translated by service provider (as part of provider assessment)
Develop, maintainrelationships and collaborate with European affiliates and other industrygroups
Researchterminology on new chemical entities
Develop andmaintain Work Instructions for own area of responsibility
Review Frenchlanguage copy translated by other LS staff members or approved vendor.
Act as alternateto evaluate and authorize deviations to the process (for Labelling materialsonly).
Participate inmarketing cycle planning meetings and agency/market research briefings whenrequired.
Participate innew product launch Ops team meetings.
Advise on Frenchterminology and adaptation problems. Offer possible solutions to adaptationprojects for marketing purposes (advertising slogans, idiomatic expressions,etc.).
Contribute toin-house and vendor terminology banks.
Evaluate the needfor deviations to the process (for Labelling materials only).
Assess nature ofproject and apply manual or automated review accordingly.
Escalate tomanagement any major issue or situation that may require a deviation from theapproved procedures.
Sign off onFrench Controlled copy in Linguistic Services Manager’s absence.
Providerecommendations on improvement of processes and procedures, deviations toapproved process, optimization of written content of controlled documents andlinguistic and other related issues.
Qualifications
This positionrequires:
French nativespeaker with above average writing skills
University degreein Life Sciences or related field
Experience inFrench medical writing
A solidunderstanding of pharmaceutical industry regulations
More than 5 to 7years of experience in English-French translation/review in pharmaceutical orother related fields
ATIO/OTTIAQcertification and/or other related professional association an asset
Able to workunder tight timelines
Excellentinterpersonal and communication skills
Knowledge of CATtools (LogiTerm, Studio TRADOS), and MS Office an asset
Experience in theHealth Care Profession (Paramedics, Nursing, Doctor, Pharamacist,etc.) would be a strong asset.
Attention todetail and ability to work under pressure
BE VITAL in yourcareer. Be seen for the talent you bring to your work. Explore opportunitieswithin the Johnson & Johnson Family of Companies.
Diversity andinclusion are central elements of the shared culture across theJohnson & Johnson Family of Companies. Attracting,developing and retaining a workforce that reflects the diversity of ourcustomers and communities is essential to our success. We are committedto providing a respectful, inclusive and accessible work environment where allemployees have the opportunity to achieve their potential.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Toronto
Other Locations:North America-Canada-Ontario-Hamilton, North America-Canada-Ontario-Oakville, North America-Canada-Ontario-Oshawa, North America-Canada-Ontario-Richmond Hill
Organization: Janssen Inc. (7710)
Relocation: Eligible Yes - in Region
Travel:No
Job Function: Graphics/Technical Writing
Description
At Janssen, weare dedicated to addressing and solving some of the most important unmetmedical needs of our time in oncology, immunology, neuroscience, infectiousdiseases and vaccines, metabolic and chronic diseases and women’s health.Driven by our commitment to patients, we bring innovative products, servicesand solutions to people throughout the world. Janssen Inc. is a member of theJanssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.cafor more information.
Position Overview
The BilingualScientific Reviewer will be reviewing French language scientific and labellingcontrolled materials in accordance with current procedure while ensuringaccuracy, timeliness and cost-effectiveness.
MAJOR RESPONSIBILITIES:
Review Frenchlanguage Labeling text and other controlled materials (promotional materials,adverse event reports, etc.) for Janssen Inc.
Give finalsign-off for release of French language Labelling and other controlleddocuments
Review / approve/ negotiate changes made to French copy by PAAB or other regulatory bodies
Translatetechnical/medical content such as AE reports and patient medical records, labreports, etc. (Drug Safety and Surveillance)
Audit andevaluate files translated by service provider (as part of provider assessment)
Develop, maintainrelationships and collaborate with European affiliates and other industrygroups
Researchterminology on new chemical entities
Develop andmaintain Work Instructions for own area of responsibility
Review Frenchlanguage copy translated by other LS staff members or approved vendor.
Act as alternateto evaluate and authorize deviations to the process (for Labelling materialsonly).
Participate inmarketing cycle planning meetings and agency/market research briefings whenrequired.
Participate innew product launch Ops team meetings.
Advise on Frenchterminology and adaptation problems. Offer possible solutions to adaptationprojects for marketing purposes (advertising slogans, idiomatic expressions,etc.).
Contribute toin-house and vendor terminology banks.
Evaluate the needfor deviations to the process (for Labelling materials only).
Assess nature ofproject and apply manual or automated review accordingly.
Escalate tomanagement any major issue or situation that may require a deviation from theapproved procedures.
Sign off onFrench Controlled copy in Linguistic Services Manager’s absence.
Providerecommendations on improvement of processes and procedures, deviations toapproved process, optimization of written content of controlled documents andlinguistic and other related issues.
Qualifications
This positionrequires:
French nativespeaker with above average writing skills
University degreein Life Sciences or related field
Experience inFrench medical writing
A solidunderstanding of pharmaceutical industry regulations
More than 5 to 7years of experience in English-French translation/review in pharmaceutical orother related fields
ATIO/OTTIAQcertification and/or other related professional association an asset
Able to workunder tight timelines
Excellentinterpersonal and communication skills
Knowledge of CATtools (LogiTerm, Studio TRADOS), and MS Office an asset
Experience in theHealth Care Profession (Paramedics, Nursing, Doctor, Pharamacist,etc.) would be a strong asset.
Attention todetail and ability to work under pressure
BE VITAL in yourcareer. Be seen for the talent you bring to your work. Explore opportunitieswithin the Johnson & Johnson Family of Companies.
Diversity andinclusion are central elements of the shared culture across theJohnson & Johnson Family of Companies. Attracting,developing and retaining a workforce that reflects the diversity of ourcustomers and communities is essential to our success. We are committedto providing a respectful, inclusive and accessible work environment where allemployees have the opportunity to achieve their potential.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Toronto
Other Locations:North America-Canada-Ontario-Hamilton, North America-Canada-Ontario-Oakville, North America-Canada-Ontario-Oshawa, North America-Canada-Ontario-Richmond Hill
Organization: Janssen Inc. (7710)
Relocation: Eligible Yes - in Region
Travel:No
Job Function: Graphics/Technical Writing