Reference Number: JO-2003-447255
CMC Writer
Rate: Negotiable
Job Type: Contract
Location: Cambridge

CMC Writer Freelance
20 hours per week
Opportunity to be home based with travel to either Cambridge or Aachen Germany office
Preference for ASAP start

Regulatory Professionals is working with a leading specialty pharmaceutical company who are developing innovative anaesthesia medication. An opportunity has arisen for a CMC Freelance Writer to join their established team, working on a 20 hour a week basis, with flexibility of working from home.

Job Responsibilities include;

– Creation and maintenance of CMC documentation as part of the marketing authorisation dossier
– Input into development of regulatory strategies for the lifecycle management of a product
– Creation of necessary CMC documentation with special attention to country specific requirements
– Maintenance of multiple DMF dossiers
– Creation and maintenance of annual reports and other periodic report

Candidate Requirements include;

– Life Sciences degree of the equivalent
– Prior experience with eCTD dossiers, especially M3 and DMF dossier maintenance
– Prior pharmaceutical experience
– Fluent in English with good knowledge of German
– Experience in reviewing scientific information
– Experience using Document Management Systems

If this position is of interest to yourself please call Sophie at Regulatory Professionals on 0118 952 2797 or alternatively forward your up to date CV to sophie@regulatoryprofessionals.com.

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