Regulatory Affairs Specialist - Senior
Titel: Regulatory Affairs Specialist - Senior
Werkgever: Hays
Plaats: Provincie Zuid-Holland
Provincie:
Locatie:
Provincie Zuid-Holland /
Omschrijving:
Your new company
The Dossier Development & Operations Technical Integrator will be involved in Technical writing. He will be joining the CMC department. The CMC section of the vaccine is being developed by project teams, aimed at manufacturing and development.
Your new role
There is a need for a technical writing - dossier development and operations technical integration. The consultant, will be working up to 40 hours a week to support the teams with a number of scientific regulatory writing tasks including Module 3 sections and if required quality overall summaries of upcoming submissions. He will also respond to questions from Health Authorities and other written communications with the Authorities. The dossier is developed in a Company documentations system using common best practices for dossier development and formatting, it is sent for review and approvals in the system.
You will be responsible for authoring of module 3 sections and if required quality overall summaries of the upcoming submissions and responses to questions from Health Authorities and other written communications with the Authorities related to these submissions. You m ay be also involved in writing and editing Briefing Packages. You will be managing all these systems through the electronic documentation system (IBM WebSphere® based). 70% writing activities including routing modules for reviews and approvals in the documentation system, 30% communication with department subject matter experts, project leads, publishing etc.
What you'll need to succeed
Degree in Pharmacy, Biomedical Science or Life Science. Advanced degree is desirable.
Experience in working with document management systems.
Relevant work experience within the (bio) pharmaceutical industry.
Scientific & regulatory writing skills to write the proper documentation
Affinity with GMP and biotechnology/pharmaceutical processes and analytical methods.
Non-Technical profile requirements (standardized):
Strong tracking, coordination and project planning skills
Strong analytical and problem-solving skills
Must be able to work on multiple simultaneous tasks with limited supervision
Quick learner, motivated self-starter
Excellent interpersonal, communication and team collaboration skills
Able to follow change management procedures and internal guidelines
English spoken and written
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
Provincie Zuid-Holland /
Omschrijving:
Your new company
The Dossier Development & Operations Technical Integrator will be involved in Technical writing. He will be joining the CMC department. The CMC section of the vaccine is being developed by project teams, aimed at manufacturing and development.
Your new role
There is a need for a technical writing - dossier development and operations technical integration. The consultant, will be working up to 40 hours a week to support the teams with a number of scientific regulatory writing tasks including Module 3 sections and if required quality overall summaries of upcoming submissions. He will also respond to questions from Health Authorities and other written communications with the Authorities. The dossier is developed in a Company documentations system using common best practices for dossier development and formatting, it is sent for review and approvals in the system.
You will be responsible for authoring of module 3 sections and if required quality overall summaries of the upcoming submissions and responses to questions from Health Authorities and other written communications with the Authorities related to these submissions. You m ay be also involved in writing and editing Briefing Packages. You will be managing all these systems through the electronic documentation system (IBM WebSphere® based). 70% writing activities including routing modules for reviews and approvals in the documentation system, 30% communication with department subject matter experts, project leads, publishing etc.
What you'll need to succeed
Degree in Pharmacy, Biomedical Science or Life Science. Advanced degree is desirable.
Experience in working with document management systems.
Relevant work experience within the (bio) pharmaceutical industry.
Scientific & regulatory writing skills to write the proper documentation
Affinity with GMP and biotechnology/pharmaceutical processes and analytical methods.
Non-Technical profile requirements (standardized):
Strong tracking, coordination and project planning skills
Strong analytical and problem-solving skills
Must be able to work on multiple simultaneous tasks with limited supervision
Quick learner, motivated self-starter
Excellent interpersonal, communication and team collaboration skills
Able to follow change management procedures and internal guidelines
English spoken and written
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
