Senior Specialist Medical Writing
Senior Specialist Medical Writing
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Job Description
Purpose Statement
Prepare highquality and accurate NDArelated documents (CSR CTD etc. in accordance with regulatory requirements based on policies of global R&D and Japan Development.
Formulate strategies such as policy schedule budget etc. for preparation of NDArelated documents as a leadwriter of the project in charge.
Major Responsibilities:
For Grade 16 Senior Specialist
Prepare NDArelated documents and arrange their quality control as a leadwriter.
Make every effort to prepare highquality NDArelated documents in accordance with pharmaceutical regulations SOPs manuals etc.
Contribute to the decision making of the assigned JPT on behalf of Medical Writing Group.
Contribute to the assigned JPT by the support of developing regulatory documents such as answers to regulatory queries and briefing books.
Formulate strategies such as policy schedule budget etc. for preparation of NDArelated documents of the project in charge and propose them to JPT.
Prepare appropriate procedures for development and maintenance of NDArelated documents.
Build cooperative relationships with stakeholders in Global MW.
Prepare/update appropriate procedures for the vendor management.
Conduct liaison activities with the vendor regarding preparation of NDArelated documents.
Support to develop other medical writers who they cooperate with with the support of the supervisors if necessary.
Qualifications :
Bachelors degree in pharmacy biology chemistry pharmacology or other related academic area or equivalent ability is required. Masters or doctors degree is preferred.
TOEIC 700 or more or equivalent English communication skill are required.
At least 5 years experience in or equivalent skill for clinical development regulatory affairs postmarketing surveillance including any medical writing experience.
Experience of attending the medical writing training course hosted by an organization (e.g. Union of Japanese Scientists and Engineers
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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No
Employment Type :
Fulltime
Employment Type
Full-time
