Regulatory Writer
Year Bengaluru, Karnataka, India
Job Description
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Overview of role The Regulatory Writer is expected to work on assignments largely independently or for complex documents facilitating the delivery of the written assignments through proactive coordination of stakeholders to build content. The writer understands clinical trial design and interpretation of statistically analysed clinical research data as well as regulatory implications for dossier writing (e.g. eCTD module 2 nonclinical/clinical). The Regulatory Writer would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The writer is responsible for the final deliverable and is expected to work in complex matrix organizations. Scope and responsibility:
- Authors a range of regulatory documents with clinical scope following defined templates, including but not limited to BLA/MAA eCTD submission documents (with focus on, but not limited to eCTD module 2 nonclinical/clinical), briefing documents, and responses to regulatory authority questions.
- Ensures high integrity of data interpretation, following negotiation with the team.
- Ensures the consistency and quality level of all documents that are issued.
- Actively participates in all planning, coordination and review meetings.
- Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability to promote high medical/regulatory writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
- Establishes a network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in the delivery of writing assignments.
- BSc degree or equivalent
- 5+ years of clinical/regulatory writing experience in the pharmaceutical industry (authoring BLA/MAA/IND/BB)
- Expertise in global dossier authoring for biologics/biosimilars (EMA/FDA) (preferred)
- Completes assignments independently or for more complex documents, under the guidance of a subject matter expert.
- Possesses a good understanding of basic drug development of biotechnology-derived medicinal products.
- Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
- Demonstrates understanding of how to interpret, describe and document clinical/non-clinical data in the context of EMA and FDA regulatory framework.
- Possesses working knowledge of the International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Previous experience in projects with biosimilars would be of advantage.
- Option to work hybrid.
- An inspiring challenge to work with great co-workers on ambitious projects that change people\'s lives.
- The chance to be part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration, and inclusion.
- Positive, flexible, and innovative work environment.
- A clear and developed organizational structure.
- Training and global opportunities to advance.
- A good work-life balance.
- Home internet and home office equipment.
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Job Detail
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Job IdJD3034962
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBengaluru, Karnataka, India
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EducationNot mentioned
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ExperienceYear