Job Details

Requisition Number 17-0067
Post Date 9/19/2017
Company Akcea
Title Regulatory Affairs Director/Pharmacist, Akcea FR
Employment Type Full Time
Description

Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.

Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics. In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”

 

In September of 2017 Akcea formally established an entity in France, Akcea Therapeutics France, SAS.

Pharmacist Responsible. Regulatory Affairs Director France & BeNeLux. Regional Compliance Officer Responsibilities:

Requirements:

  • Regulatory affairs :
  • Filling and submission of opening authorization application for the exploitant facility
  • Filling and submission of annual facility master file (once a year)
  • Follow-up of MA application with Health competent authority (ANSM):
    • Responses to questions
    • Notification of off label use
  • Implementation of change control after regulatory approvals (MA, variations, risk management plan, etc.):
    • Update of packaging, procedures, promotional/non promotional material
    • Information of competent authorities (CEPS, HAS, etc.)
    • Information of subsidiaries (wholesaler, etc.)
  • Packaging and traceability management:
    • Datamatrix and serialization coding follow-up with HQ
  • Temporary Authorization for Use management:
    • Filling application to Health authority
    • Implementation of protocol for therapeutic use
    • Validation of packaging
    • Distribution management
    • Drug safety management
  • Marketing monitoring (report to health authority on initial marketing date, prohibition or restriction decisions or any information that can influence the benefit to risk assessment)
  • Medical advertising and information
    • Promotional and non-promotional material review and validation
    • Review and submission to Health authority of promotional material
    • Non-promotional material review and validation
    • Logistical management of material with traceability (withdrawal, archiving, etc.)
  • Training material :
    • Implementation of training process
    • Review and validation of training material for REPs and employees
    • Evaluation of skills
  • Free samples and donated products management
  • Archiving management
  • Risk management approach (document management, complaints, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan
  • Supervision of pharmaceutical contracts (HQ and outsourced activities)
  • Clinical studies follow-up (for studies with French investigators centers)
  • Drug safety management (with operational delegation to subsidiary or medical department):
  • Implementation of pharmacovigilance process
  • Nomination of local QP PV
  • Interaction with European QP PV and European database
  • Procedures and data management
  • Report to Competent authorities
  • Collection, registration, assessment, report and follow-up of adverse events
  • Screening of scientific and medical literature for PV relevant information
  • Signal detection
  • Review and validation of PSUR
  • Reconciliation of shared PV data
  • Implementation of KPI
  • Report of off-label use to French authority
  • Medical information management (with operational delegation to subsidiary or medical department) :
  • Implementation of medical information process (data management, standard responses, access to literature database)
  • Collection, registration and response to medical information requests
  • Reconciliation of shared medical information data
  • Implementation of KPI

 

  • Quality assurance :
  • Conduction of regular audits of internal pharmaceutical activities (drug safety, medical information, promotion process, complaints, etc.)
  • Regular audits and inspections from authorities (ANSM, etc.)
  • Batch release for distribution in France and tracking/traceability
  • Batch recall management with MAH, Health authority and wholesaler
  • Shortage management with Health authority:
    • Report to Health authority (ANSM)
    • Implementation of shortage management plan (preventive and corrective actions, contingency plan, communication, etc.)
    • Communication with DHCP letter (Dear Health care professional letter)
  • Supply management with HQ :
    • Forecast trollies
    • Temperature transportation and traceability
    • Importation authorizations
  • Storage and distribution management with wholesaler :
    • Procedures for storages (temperature, secured storage, FEFO/FIFO, etc.)
    • Transport conditions (temperature, delays for delivery, risk analysis process, subcontracting management, etc.)
    • Order management
    • Return management
    • Deviations management
  • Quality complaints:
    • Implementation of complaint process
    • Collection, registration, assessment, report to manufacturer and follow-up of investigation results
    • Reconciliation of shared complaints data
    • Implementation of KPI
  • SOPs :
    • Creation and update of pharmaceutical SOP (PV, medical information, promotion, batch traceability, complaints, etc.)
    • Implementation and training
  • Sales representatives charter
    • Implementation of certification process
    • Continuous improvement measures
    • Quality policy and code of ethics
    • Medical sales visit
    • Training and assessment
    • Guidance on MSL and REPs communication
  • Quality compliance implementation:
    • Compliance to GMP, GDP , GPVP, Medical Sales representatives Charter
  • Audits planning, execution and follow-up :
    • Sales representatives charter
    • Suppliers (wholesaler, subsidiaries)
    • Inspections by Competent Authorities
    • Self-inspections
  • KPI (definition, collection and analysis of KPI for major pharmaceutical activities)
  • Compliance management (with operational delegation to subsidiary or legal department):
  • Implementation of French sunshine act:
    • Submission of applications for hospitality interaction to Competent authority for each event or interaction (CNOM, CNOP, CNOI)
    • Disclosure of transfer of value with HCPs, organizations (twice a year)
  • Implementation of guidelines on interactions with HCPs, Providers, Payers and Patient Organizations
  • Legal review of agreements with HCPs, hospitals, organizations, etc.
  • Personal data protection management
    • Designation of a data protection officer
    • Procedures implementation
    • Submission of applications for data processing to Competent authority (CNIL)

 

Excellent salary and benefits package offered.

For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com Reference #170067

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Akcea Therapeutics, Inc. is proud to be an EEO employer.

 

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