We have vacancy for Product information expert role in Regulatory Affairs team. We are looking for Specialist- Product information Specialist. The candidate has the possibility to utilize his/her own strengths with the support of the specialists.
Your key responsibilities
Management and coordination of good quality PI documents such as company core data sheets (CCDS), Summary of Product Characteristics (SmPCs), package leaflets (PLs) and labelling in close co-operation with Regulatory Affairs and Pharmacovigilance, including Writing PI documents with support from Medical Affairs, Commercial Operations and Global Operations
Document management and change control of PI documents
Performing quality control of PI documents for accuracy and consistency
Global coordination and guidance of internal PI related processes
Assuring high quality processes, internal guidelines, standard operating procedures internal templates
Requirements
4 - 7 years of experience as Product Information Specialist in Pharmaceutical industry
Advanced writing skills (e.g. SmPC, PL, other regulatory documents)
Ability to understand complex medical terminologies and convert them into straightforward language
Advanced computer and word processing (MS Word, Adobe Acrobat) skills
Valuable communication and interpersonal skills
Ability to prioritise, manage multiple projects meet deadlines while delivering high quality documents
Ability to work within teams (often remotely) as well as independently
Positive attitude and willingness to learn and adapt, but also to teach and support co-workers and colleagues around the world
Ability to keep sight of the bigger picture, while at the same time paying attention to details.
Ability to work in a highly regulated industry
Qualifications
Bachelor's/Master's degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college
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