Novo Nordisk Hiring Medical Writer in the Global Development (GD) Graduate (PhD, MSc., M Pharm, or equivalent) Apply Now
The position
Your main
responsibility will be to perform medical writing tasks including protocol
writing, preparation of Clinical trial reports (CTRs), Clinical summary
documents in CTD/eCTD format for regulatory submissions world-wide (including
investigational medicinal product dossiers (IMPDs), investigational new drug
applications (INDs), marketing authorisation applications (MAAs), new drug
applications (NDAs), variations and supplemental new drug applications (sNDAs),
redaction of CTRs and QC of the redacted CTRs, results tables/Data
Sets/synopses to clinical trial registries (ct.gov, EUCTR, pharmanet. bund
etc), other relevant ad-hoc documents.
You will also
have to contribute to knowledge sharing, skill building and good collaboration
with stakeholders and colleagues and participate in internal/external
marketing/medical activities, e.g., expert meetings, lectures and conferences.
You will contribute to ongoing improvements in cross-functional and global
collaboration and sharing of better practices and knowledge, also contribute to
process improvements, maintain up-to-date knowledge and competencies within
relevant therapeutic and professional areas.
You will
actively participate in relevant meetings, training sessions and seminars in
the department, competency anchor and relevant project(s) and maintain a good
working relationship with stakeholders and colleague. Your key stakeholder will
be the work is complex and involves close collaboration with stakeholders
world-wide with different professional and cultural backgrounds. The majority
of the relevant stakeholders are located in HQ, Trial managers, international
medical officers, regulatory affairs, and marketing are dependent on the
documents produced by medical writers, these documents include: CTRs and CTD
clinical summary and overview documents - needed for the approval of labelling
changes and new drugs, IBs, and the clinical sections of IMPDs/INDs - key
documents for initiating new trials, Clinical trial results presentations for
distribution to clinical investigators – contribution to the good working
relationship with investigators. The ability of the medical writer to meet
requirements to both quality and timelines is thus important for the reputation
and financial results of the company.
Qualifications
You are
expected to have the below skills and knowledge:
Graduate
(PhD, MSc., M Pharm, or equivalent)
≥ 2 years of
experience with scientific research methodology, including designing and
conducting experiments, and analysing and reporting experimental results
Experience
from the pharmaceutical /CRO industry
Works
independently on smaller tasks
Strong
analytical skills
Committed,
persistent and accountable
Able to
manage variable work load
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