Job Description

McKesson touche la vie des patients en \xc5\x93uvrant dans pratiquement tous les secteurs des soins de sant\xc3\xa9 dans le but d\xe2\x80\x99am\xc3\xa9liorer la sant\xc3\xa9 en g\xc3\xa9n\xc3\xa9ral. Chez McKesson Canada, nous cr\xc3\xa9ons un impact dans la vie de 12 millions de Canadiens, chaque jour. Nous distribuons plus de 35 000 produits \xc3\xa0 partir de 12 centres de distribution \xc3\xa0 6 300 pharmacies de d\xc3\xa9tail, 1 350 h\xc3\xb4pitaux, centres de sant\xc3\xa9 longue dur\xc3\xa9e, cliniques et \xc3\xa9tablissements de sant\xc3\xa9 partout au Canada. Toutefois, nous sommes beaucoup plus qu\'une entreprise de distribution. Nous avons automatis\xc3\xa9 2 500 pharmacies de d\xc3\xa9tail et distribuons annuellement plus de 100 millions de doses de m\xc3\xa9dicaments gr\xc3\xa2ce \xc3\xa0 nos solutions d\'automatisation. Les fabricants, les fournisseurs de soins de sant\xc3\xa9 et les patients comptent sur nous pour une gamme compl\xc3\xa8te de services qui contribuent \xc3\xa0 la qualit\xc3\xa9 et l\'int\xc3\xa9grit\xc3\xa9 des soins de sant\xc3\xa9 pour le b\xc3\xa9n\xc3\xa9fice de tous.

Chez McKesson, vous participerez \xc3\xa0 la cr\xc3\xa9ation de produits et de solutions qui contribuent \xc3\xa0 la r\xc3\xa9alisation de la mission de l\xe2\x80\x99entreprise, soit am\xc3\xa9liorer la qualit\xc3\xa9 de vie et faire progresser les soins de sant\xc3\xa9. Travailler ici repr\xc3\xa9sente une occasion d\xe2\x80\x99\xc3\xa9difier une industrie qui est vitale pour nous tous.

R\xc3\xa9sum\xc3\xa9 du poste

En tant que d\xc3\xa9l\xc3\xa9gu\xc3\xa9 du chef principal, Affaires r\xc3\xa9glementaires, le sp\xc3\xa9cialiste en affaires r\xc3\xa9glementaires est charg\xc3\xa9 de effectuer des activit\xc3\xa9s reli\xc3\xa9es \xc3\xa0 la r\xc3\xa9glementation afin de maintenir les licences de McKesson Canada et des soci\xc3\xa9t\xc3\xa9s affili\xc3\xa9es conform\xc3\xa9ment \xc3\xa0 la r\xc3\xa9glementation.

Section A \xe2\x80\x93Responsabilit\xc3\xa9s Sp\xc3\xa9cifiques

• Pr\xc3\xa9parer, r\xc3\xa9viser et compiler les soumissions de licence crois\xc3\xa9e de haute qualit\xc3\xa9 pour les m\xc3\xa9dicaments et les instruments m\xc3\xa9dicaux de marque priv\xc3\xa9e pour s\'assurer qu\'elles sont compl\xc3\xa8tes et conformes aux lignes directrices applicables d\xc3\xa9crites par Sant\xc3\xa9 Canada.
• R\xc3\xa9viser et approuver les \xc3\xa9tiquettes des m\xc3\xa9dicaments et des instruments m\xc3\xa9dicaux de marque priv\xc3\xa9e avant leur mise en vigueur (d\xc3\xa9l\xc3\xa9gu\xc3\xa9 des affaires r\xc3\xa9glementaires pour signature, selon le besoin).
• Initier les contr\xc3\xb4les de changements reli\xc3\xa9s aux mises \xc3\xa0 jour des \xc3\xa9tiquettes et compl\xc3\xa9ter leur \xc3\xa9valuation r\xc3\xa9glementaire.
• Pr\xc3\xa9parer, reviser et compiler les soumissions de mises \xc3\xa0 jour des monographies de produit \xc3\xa0 Sant\xc3\xa9 Canada et contribuer \xc3\xa0 la mise en place d\xe2\x80\x99un programme de gestion des monographies de produits afin de garantir que les produits de Sivem sont conformes \xc3\xa0 leur soumission r\xc3\xa9glementaire et aux mises \xc3\xa0 jour d\xe2\x80\x99innocuit\xc3\xa9.
• Pr\xc3\xa9parer, reviser et compiler des soumissions de haute qualit\xc3\xa9 aux formulaires provinciaux pour s\'assurer qu\'elles sont compl\xc3\xa8tes et conformes aux lignes directrices applicables \xc3\xa9nonc\xc3\xa9es par les autorit\xc3\xa9s provinciales et les payeurs priv\xc3\xa9s.
• Mettre en \xc5\x93uvre un plan pour s\'assurer que l\'enregistrement des produits aupr\xc3\xa8s des autorit\xc3\xa9s provinciales et des payeurs priv\xc3\xa9s est effectu\xc3\xa9 \xc3\xa0 temps.
• Se renseigner et faire le suivi avec les r\xc3\xa9gimes d\'assurance-m\xc3\xa9dicaments provinciaux pour r\xc3\xa9soudre les probl\xc3\xa8mes de remboursement.
• Contribuer au d\xc3\xa9veloppement de moyens innovateurs pour surmonter les d\xc3\xa9fis de remboursement.
• Tel que d\xc3\xa9l\xc3\xa9gu\xc3\xa9 par le gestionnaire, Affaires r\xc3\xa9glementaires, effectuer une \xc3\xa9valuation r\xc3\xa9glementaire des contr\xc3\xb4les de changement initi\xc3\xa9s par d\'autres d\xc3\xa9partements.
• Analyser les informations sur les produits pour compiler et communiquer les notifications annuelles de m\xc3\xa9dicaments et les renouvellements annuels des homologations d\'instruments m\xc3\xa9dicaux \xc3\xa0 Sant\xc3\xa9 Canada.
• Responsable des activit\xc3\xa9s r\xc3\xa9glementaires reli\xc3\xa9es aux renouvellements et modifications de licences d\xe2\x80\x99\xc3\xa9tablissements de drogues et licences d\xe2\x80\x99\xc3\xa9tablissements d\xe2\x80\x99instruments m\xc3\xa9dicaux.

• Envoyer aux fournisseurs, tel que demand\xc3\xa9, les licences de pr\xc3\xa9curseurs, licences de narcotiques et substances contr\xc3\xb4l\xc3\xa9es avec les signatures autoris\xc3\xa9es reli\xc3\xa9es, les licences de drogues contenant du cannabis et d\xe2\x80\x99autres licences tel que requis.
• Travailler avec le chef principal, Affaires r\xc3\xa9glementaires sur des projets d\'am\xc3\xa9lioration des processus et contribuer \xc3\xa0 la pr\xc3\xa9paration / mise \xc3\xa0 jour des proc\xc3\xa9dures op\xc3\xa9rationnelles normalis\xc3\xa9es (SOP) et des instructions de travail (WI) li\xc3\xa9es aux activit\xc3\xa9s des affaires r\xc3\xa9glementaires.

Section B \xe2\x80\x93 Responsabilit\xc3\xa9s G\xc3\xa9n\xc3\xa9rales

• Maintenir les indicateurs de performance cl\xc3\xa9s du d\xc3\xa9partement pour atteindre les objectifs de l\xe2\x80\x99entreprise.
• Travailler en \xc3\xa9troite collaboration avec le directeur principal des affaires r\xc3\xa9glementaires pour d\xc3\xa9velopper une strat\xc3\xa9gie r\xc3\xa9glementaire et r\xc3\xa9pondre \xc3\xa0 toutes les questions r\xc3\xa9glementaires soulev\xc3\xa9es par l\'entreprise.
• Effectuer d\'autres t\xc3\xa2ches, au besoin, d\xc3\xa9l\xc3\xa9gu\xc3\xa9es par le gestionnaire des affaires r\xc3\xa9glementaires ou le directeur principal des affaires r\xc3\xa9glementaires.
• Agir \xc3\xa0 titre de rempla\xc3\xa7ant pour le chef principal, Affaires r\xc3\xa9glementaires, au besoin.

Section C \xe2\x80\x93 Exigences cl\xc3\xa9s du poste

\xc3\x89ducation

• Dipl\xc3\xb4me universitaire en sciences, sciences de la sant\xc3\xa9 ou pharmacie, ou exp\xc3\xa9rience pertinente dans l\'industrie pharmaceutique.

Comp\xc3\xa9tences techniques et g\xc3\xa9n\xc3\xa9rales

• 5 ans dans un r\xc3\xb4le aux affaires r\xc3\xa9glementaires / conformit\xc3\xa9 dont 2 ans dans les soumissions r\xc3\xa9glementaires en format eCTD.
• Connaissance des documents des lignes directrices de Sant\xc3\xa9 Canada relatifs aux soumissions de m\xc3\xa9dicaments ainsi qu\'aux licences.
• Connaissance de la r\xc3\xa9glementation canadienne sur le remboursement et capacit\xc3\xa9 d\'interpr\xc3\xa9ter les politiques et les lignes directrices. La connaissance de la fabrication de proc\xc3\xa9d\xc3\xa9s pharmaceutiques est un atout.
• Solides comp\xc3\xa9tences multit\xc3\xa2ches et gestion de projets.
• Flexibilit\xc3\xa9 et capacit\xc3\xa9 \xc3\xa0 s\'adapter rapidement aux changements des besoins / demandes des clients et aux changements dans l\'environnement de travail.
• Capacit\xc3\xa9 bien d\xc3\xa9velopp\xc3\xa9e \xc3\xa0 coop\xc3\xa9rer avec les autres dans des situations de r\xc3\xa9solution de probl\xc3\xa8mes urgentes et complexes.
• Bonne compr\xc3\xa9hension des BPF et des bonnes pratiques de documentation au Canada.
• Exp\xc3\xa9rience en gestion de la documentation et en syst\xc3\xa8me de gestion de la qualit\xc3\xa9.
• Excellentes comp\xc3\xa9tences en communication verbale et \xc3\xa9crite et en pr\xc3\xa9sentation.
• Ma\xc3\xaetrise d\xe2\x80\x99Adobe Acrobat et des produits de Miscrosoft, y compris mais sans s\xe2\x80\x99y limiter \xc3\xa0, Windows, Word, Excel, Power Point, Outlook.
• Capacit\xc3\xa9 \xc3\xa0 obtenir des r\xc3\xa9sultats avec un minimum de supervision dans un environnement d\'\xc3\xa9quipe.
• Bilinguisme - fran\xc3\xa7ais / anglais (parl\xc3\xa9 / \xc3\xa9crit).

Le.la titulaire de ce poste aura \xc3\xa0 soutenir de fa\xc3\xa7on quotidienne des clients internes et/ou externes \xc3\xa0 l\xe2\x80\x99ext\xc3\xa9rieur du Qu\xc3\xa9bec et/ou aux \xc3\x89tats-Unis. Par cons\xc3\xa9quent, ce poste requiert une ma\xc3\xaetrise de l\xe2\x80\x99anglais \xc3\xa0 l\xe2\x80\x99\xc3\xa9crit et \xc3\xa0 l\xe2\x80\x99oral. Veuillez noter que le nombre de postes dont les t\xc3\xa2ches requi\xc3\xa8rent une connaissance de la langue anglaise a \xc3\xa9t\xc3\xa9 restreint dans la mesure du possible.

McKesson is in the business of better health, and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we\'re so much more than a distribution company. We\'ve automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.

At McKesson Canada, you\xe2\x80\x99ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that\xe2\x80\x99s vital to us all.

Job Summary

As the delegate to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Specialist is responsible of performing regulatory activities to maintain the licences of McKesson Canada and affiliated companies in compliance with the regulations.

Section A \xe2\x80\x93 Specific Responsibilities

• Prepare, review and compile high-quality cross licensing submissions for drugs and private label medical devices to ensure they are complete and compliant with applicable guidelines outlined by Health Canada.
• Review and approve the labels of drugs and private label medical devices prior implementation (signing delegate for Regulatory as required).
• Initiate change controls related to labels updates and complete their regulatory assessment.
• Prepare, review and compile Product Monograph updates submissions to Health Canada and contribute to the implementation of a program to manage Product Monographs to ensure that Sivem\xe2\x80\x99s products are compliant to their regulatory filing and safety updates.
• Prepare, review and compile high-quality provincial formularies submissions to ensure they are complete and compliant with applicable guidelines outlined by the provincial authorities and the private payers.
• Execute plan to ensure products registration with provincial authorities and private payers is done on time.
• Investigate and follow up with provincial drug plans to resolve reimbursement issues.
• Contribute to the development of innovative ways to overcome reimbursement challenges.
• As delegated by the Senior Manager, Regulatory Affairs, complete regulatory assessment of change controls initiated by other departments.
• Analyze product information to compile and communicate annual drug notifications and annual renewals of medical devices licences to Health Canada.
• Responsible for regulatory activities around renewals and amendments to Drug Establishment Licences DEL and Medical Devices Establishment Licences MDEL.
• Provides to our vendors, as requested, the most up-to-date Precursors licences, Narcotics and Controlled Drugs and Substances licences with related Signing Authority lists, Cannabis drug licences and other licences as required.
• Work with the Senior Manager, Regulatory Affairs on process improvement projects and contribute in the preparation/updates of Standard Operating Procedures (SOPs) and Working Instructions (WI) related to regulatory affairs activities.

Section B \xe2\x80\x93 General Responsibilities

• Maintain department KPI to achieve the business goals.
• Work closely with the Senior Director Regulatory Affairs to develop a regulatory strategy and answer any regulatory questions raised by the business.
• Perform other tasks as required delegated by the Senior Manager, Regulatory Affairs or the Senior Director Regulatory Affairs.
• Act as a backup for Senior Manager, Regulatory Affairs when required.

Section C \xe2\x80\x93 Position Key Requirements

Education

• University degree in Science, Health Sciences or Pharmacy, or relevant experience in the pharmaceutical industry.

Technical and Soft Skills

• 5 years in Regulatory/ Compliance functions including 2 years in regulatory filings in the eCTD format.
• Knowledge of Health Canada guidance documents related to drug submissions as well as to licensing.
• Knowledge of the Canadian reimbursement regulations and ability to interpret policies and guidelines. Knowledge of pharmaceutical process manufacturing is an asset.
• Strong multi-tasking and project management skills,
• Flexibility and ability to adapt quickly to changing customer needs/demands and environment changes,
• Well-developed ability to cooperate with others in urgent and complex problem-solving situation,
• Solid understanding of GMP and Good Documentation Practices in Canada
• Documentation Management and Quality system management experience
• Excellent verbal and written communication and presentation skills,
• Proficient with Adobe Acrobat and Microsoft Office products, including but not limited to, Windows, Word, Excel, Power Point, Outlook
• Ability to obtain results with minimal supervision in a team environment,
• Bilingualism - French/ English (speaking/ writing).

The incumbent of this position will provide daily support to internal and/or external clients outside Quebec and/or in the United States. Therefore, he/she must be proficient in spoken and written English. Please note that the number of positions requiring English language skills has been limited where possible.

Career Level \xe2\x80\x93 IC \xe2\x80\x93 Professional \xe2\x80\x93 P3

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That\xe2\x80\x99s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

$65,100 - $108,500

McKesson is an Equal Opportunity employer.

The material contained herein is provided for informational purpose only. All open jobs offered by McKesson on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.

The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links. While McKesson attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.

McKesson is an equal opportunity employer and values diversity in its workforce. We encourage applications from all qualified individuals and will accommodate applicants\' needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.

The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

Current employees must apply through internal career site.

Join us at McKesson!