Senior Medical Writer
Senior Medical Writer
As Senior Medical Writer at Cinclus Pharma, you will be part of a professional drug product development team at the Head Quarters in Stockholm, You will report to the Chief Medical Officer and you will be working together with the Clinical Development and Operations teams to produce high-quality clinical and regulatory documents that meets global standards. The medical writer will be responsible for ensuring delivery as per timelines, Standard Operating Procedures (SOPs), International GxP standards, regulations, in line with company values and long term goals.
Responsibilities
You will lead the work for medical writing activities in Cinclus Pharma projects in close collaboration with medical, operations, commercial, CMC and other relevant functions. Day to day activities may include:
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Oversight and coordination of the preparation of documentation for regulatory submissions (investigator brochures, CSRs) in technical coordination with other team members / CROs,
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Writing strategic submission documents (IMPDs, briefing documents, clinical summaries).
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Providing strategic input and expert advice on development of regulatory documentation, e.g., clinical study protocols.
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Oversight and coordination of preparation of abstracts and manuscripts for submission to scientific congresses and publications in coordination with other team members / external authors
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Coordinating the outsourcing and cooperation between Cinclus and consulting medical writers in work related to clinical and regulatory documents as well as timeline planning and participation in on-site team meetings as required.
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Develop and maintain Cinclus Pharma templates for study protocol, CSR, IB and appropriate additional clinical templates developed within Cinclus Pharma
Requirements
To be successful in this role you have experience from the field of Medical Writing within the pharmaceutical industry and/or consulting agencies. Furthermore, you:
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Have a broad Background/Knowledge, with experience within GI being a plus
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Have an adequate understanding of drug development from early phase to post submission activities
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Are familiar with submission processes to regulatory agencies
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Have experience in authoring CSRs, IBs and other regulatory documents
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Have an understanding of and are skilled within team leadership and project management
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Are fluent in written and verbal English and preferably Swedish as well.
You are used to, and enjoy, communication and collaboration both internally and externally with colleagues, authorities, and affiliates. You are creative and have an engaged, flexible and focused way of working, with the ability to see both the whole picture and the details.
Contact and application
If you are interested, please apply to the role at hr@cincluspharma.com.
If you have questions, please contact Kajsa Larsson, CMO, kajsa.larsson@cincluspharma.com.