CZK 70,000 - 100,000 • Full-time • Prague
Seniority: Senior • Education: MBA, MBT, etc.
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Pharmexon is looking for an experienced Senior Medical Writer. The role includes the responsibilities for for writing and reviewing, technically and grammatically accurate CTD Modules, Biowaiver, Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs) and Environmental Risk Assessment (ERA). The ideal candidate will have experience of current EU requirements, legislations and guidelines. In addition, the role includes the responsibility for performing systematic literature search and review to use as bibliographic support.
Prerequisites:
Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 2-4 years of regulatory writing and submission experience
Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books, literature searches.
Preferably with additional experience in review and/or creation of RMP, PSURs, PIP, ODD and waiver documents for regulatory submissions
Experience in broad spectrum therapeutic areas preferred
Ability to work with complex projects, within cross-functional teams, and under tight timelines
Requires attention to accuracy, quality, and adherence to format and stylistic requirements
Excellent grammatical and communication skills, both written and oral
Expertise in MS WORD and reference compilations
Responsibilities will include, but are not limited to, the following:
Author regulatory submission documents, eg, CSRs, CTD summary documents (2.7.3, 2.7.4, possibly 2.7.1, and 2.7.2), and Clinical Overviews (2.5), Integrated Summaries of Efficacy and Safety, Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers, and applications for Orphan Drug Designations, Provide direction to team on content and optimal data presentation/summarization in the document - Working across therapeutic areas to provide expert support as needed
Develop the strategy for document preparation and the document review processes, including the management of timelines
Facilitate document review meetings and discussions
May act as medical writing lead on submissions or new programs, including early development programs
As necessary, may assume primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
Expertise in managing Due-diligence / Audits / Monitoring activities.
Collaborate with internal and external resources to achieve high quality, timely program level submission deliverables.
WHAT Pharmexon CAN OFFER YOU:
Contribution for meal (109 CZK per working day)
25 days of annual paid time off
Multisport card for 620 CZK / month
Salary 70000-100000 CZK/month
Annual bonus program
Hybrid or remote working
Company events
Educational courses, training
Flexible start / end of working hours
Home office
Space for personal development and professional growth
Self-organization of the job
Job position benefits
