OPENING FOR REGULATORY MEDICAL WRITER (Jobcode: SANRMW14/1) 2-3 Years Experience RESPONSIBILITIES: 1. In collaboration with other relevant line functions, act as medical writing lead i.e. author independently or give directions to internal / external writers for clinical and regulatory documents, including Investigator Brochures, Clinical Study Reports (CTD Module 5), Integrated Summaries of Efficacy and Safety (CTD Module 5 for FDA), Clinical Summaries of Efficacy (CTD Section 2.7.3) and Safety (CTD Section 2.7.4), Clinical Overview (CTD Section 2.5), Pediatric Investigation Plan, Proposed Pediatric Study Request, Requests of Product Specific Waiver and Confirmation of the Applicability of Class Waiver, applications for Orphan Drug Designations, and responses to health authorities. While planning and working on these deliverables, exercise a high multi-departmental impact by driving the therapeutic area results 2. Direct the entire document portfolio required for a project (eg, an NDA submission), provide direction to teams and external writers on document content; provide innovative solutions to cross-functional areas 3. Identify resource issues. Determine how to allocate resources to meet timelines 4. In collaboration with medical writing and other functions, prepare internal guidelines for document preparation and templates for clinical documents that are consistent with EMA, FDA, ICH, and electronic submission guidelines 5. Develop the strategy for document preparation and the document review processes, including the management of timelines that meet or exceed company standards 6. Facilitate document review meetings and discussions 7. Participate in the development of resourcing plans for medical writing 8. Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements 9. Train and serve as mentor for medical writers, senior medical writers and other principal writers QUALIFICATIONS: Minimum of BACHELOR degree in science/Pharmacy/Medicine (Masters and PhD preferred) with approximately 3+ years of regulatory writing & submissions experience. Lead of at least 2 submissions (i.e., accountable for the preparation of all summary documents). SKILLS/KNOWLEDGE REQUIRED: • Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use • Knowledgeable in preclinical development including discovery, toxicology etc. • Knowledgeable in EMA, FDA and ICH guidelines • Ability to predict potential problems before they arise and to solve problems that do arise. Experience with deciding the best course of action • Ability to analyze industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD), and synthesize standardized solutions • Ability to work with complex projects and within cross-functional teams • Capable of effectively managing vendors and contract writers to meet timelines/project objective • Expertise in multiple therapeutic areas • Excellent grammatical and communication skills, both written and oral • Expertise in MS WORD, including the ability to solve technical problems with WORD templates • Previous leadership or supervisory/mentoring experience (1-2 years) Interested candidates can forward the profiles to HR@Sanjeevanibio
Posted on: Thu, 05 Jun 2014 08:05:05 +0000
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