Medical Writer for Regulatory Affairs
1 day ago
About Us
\ALK-Abelló, A,S is a pharmaceutical company dedicated to improving the lives of people affected by allergies.
\The Role
\We are seeking a Medical Writer to join our Clinical Reporting department, where you will work closely with key stakeholders to develop and implement clinical disclosure strategies.
\Your Key Responsibilities
\- \
- Create high-quality documents, including protocols, investigator brochures, clinical study reports, and briefing packages.\
- Collaborate with cross-functional teams to ensure alignment and effective implementation of clinical disclosure activities.\
- Stay up-to-date with clinical disclosure legislation and regulations, identifying areas for process improvement and driving change within Global Clinical Development.\
- Communicate complex data and information to various stakeholders, including senior management and external partners.\
- Contribute to the development of manuscripts for peer-reviewed journals and other publications.\\
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Requirements
\To succeed in this role, you will need:
\- \
- A relevant university degree in the natural sciences (PhD, M.Sc., or equivalent).\
- Proven experience in medical/regulatory writing, with a strong understanding of the clinical development value chain.\
- Experience with clinical disclosure activities and a demonstrated ability to adapt to changing requirements.\
- Strong communication and collaboration skills, with the ability to build relationships with cross-functional teams and external partners.\
- Excellent writing and analytical skills, with fluency in written and spoken English.\\
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