Senior Regulatory Writer
Senior Regulatory Writer
Posted on :
19-05-2025
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1 Vacancy
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Job Description
Band
Level 4Job Description Summary
To write review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentationrelated consultancy to other line functions. To coach/mentor and/or train less experienced writers.Job Description
Major accountabilities:
- To author review and/or independently manage high quality clinical and safety documents: Clinical Study Protocols (CSP) and protocol amendments complex Clinical Study Reports (CSR) Risk Management Plans (RMP) complexCTDsubmissiondocuments(clinicaloverviewssummariesofclinicalefficacy and safety summaries of clinical pharmacology and biopharmaceutics) other documents for health authorities (e.g. Briefing Books answers to questions).
- Leadwritingteamforcomplexsubmissionsactivelycontributingtokeymessagingand pooling strategyprovidingexpertcontent guidancefor clinicalportionsoftheCTDand ensuring compliance of documentation to internal company standards and external regulatory guidelines
- ad hoc member of Clinical Trial Team (CTT) /extendedmember of SafetyManagement Team (SMT). Core member of multiple Clinical Submission Teams (CST).
- Inputintoplanningofdataanalysesandpresentation(statisticalanalysisplanreviewand meetings) used in CSRs submission documents and/or answers to questions.
- Documentation expert in GCTs and CSTs to ensure compliance to internal company standardsandexternalregulatoryguidelines.
- Providecontentandstrategicexpertisefor clinical portions of the CTD.
- ProgramWriterforlargeand/orcomplexprogramsensuringadequatemedicalwriting resources are available for assigned program and consistency between documents.
- LeadprocessimprovementinRWSandcrossfunctionalinitiativesand/oractivities.
- mentor less experienced writers.
- Leaderincrossfunctional communication to optimize feedback and input towardshigh quality documents.
Role Requirements
- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- Fluent English (oral and written).
- Extensive medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge plus expert knowledge of medical writing processes.
- Expert knowledge extensive experience and demonstrated record of accomplishment in global registering of drugs.
- Expert knowledge of biostatistics principles.
- Proven ability to drive and manage organizational and team performance across cultures.
- Proven track record in matrix environment
- Repeat experience in managing global crossfunctional teams or complex global projects.
- Demonstrated ability to motivate and coach people.
Benefits and rewards:
Read our handbook to learn about all the ways well help you thrive personally and professionally:
We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve
Skills Desired
Clinical Research Clinical Studies Clinical Study Protocols Clinical Study Reports Clinical Trials CrossFunctional Teamwork DetailOriented Documentations Medical Writing Project Management Regulatory Compliance Regulatory Requirements Safety Stakeholder Management Waterfall ModelRequired Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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