Technical Writer (Pharma)
Titel: Technical Writer (Pharma)
Werkgever: Ajilon
Plaats: Leiden
Provincie: Zuid-Holland
Locatie:
Leiden
Werkzaamheden:
As a technical Writer you are responsible for writing CMC documentation for Vaccine Development and Production You are responsible for regulatory writing including Module 3 sections and if required quality overall summaries of upcoming submissions as well as responses 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. Primary Tasks and responsibilities • 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 • May be also involved in writing and editing Briefing Packages. • Managing 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.
Profiel:
• 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 • Excellent command of the English language, both in writing and speaking Furthermore you have strong coordination and project planning skills. You have a technical and analytical insight. Also the ability to work on multiple tasks simultaneously with limited supervision.
Bedrijfsinformatie:
Our client is one of the world's leading Biotech companies.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
Leiden
Werkzaamheden:
As a technical Writer you are responsible for writing CMC documentation for Vaccine Development and Production You are responsible for regulatory writing including Module 3 sections and if required quality overall summaries of upcoming submissions as well as responses 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. Primary Tasks and responsibilities • 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 • May be also involved in writing and editing Briefing Packages. • Managing 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.
Profiel:
• 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 • Excellent command of the English language, both in writing and speaking Furthermore you have strong coordination and project planning skills. You have a technical and analytical insight. Also the ability to work on multiple tasks simultaneously with limited supervision.
Offer:
Working at one of the world’s leading biotech companies with a good salary and secondary conditions.More information:
Please contact us on technologylifescience@ajilon.nl and refer to job no 13.365.023How to apply:
Send your CV and written motivation to technologylifescience@ajilon.nl and refer to job no 13.365.023 or use the application buttonBedrijfsinformatie:
Our client is one of the world's leading Biotech companies.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
