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Vacancy as Regulatory Affairs Publisher at Kinapse

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Our expert teams partner with our clients to advise on strategy and operations, implement capability-building programs and deliver outsourced operational solutions.  Bringing Different Perspectives  We bring industry insights and technical expertise throughout our engagements. We develop actionable recommendations and innovative solutions which are implemented successfully. Our clients are the world’s leading life sciences organisations, their customers, suppliers and regulators. Our client references are the strongest testament to the exceptional results we deliver in partnership with them.

Post : Regulatory Affairs Publisher

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Job Description 
As a Publisher for the Kinapse Global Operations Team to Clients, the Publisher will work closely with the Global Operations Team Leader, Senior Publisher, Strategic Authors and CMC support operators to ensure delivery of the contractual Client product portfolio above and beyond Client’s expectations for quality, efficiency and productivity.

Global Operations Functional Team Performance     

  • Support the publication of high quality regulatory submissions to health and regulatory authorities worldwide    
  • Ability to manage workload capacity with ever changing deadlines/requirements with ability to assist & support other members of the team where required    
  • Actively participate in development, review and process improvement activities. 

Participation in Kinapse Publishing Team     

  • Publish quality submission outputs in accordance with agreed processes, timelines, formats and standards    
  • Liaise with senior publishing colleagues and strategic author team members, both locally & globally, to ascertain individual submission requirements for specific countries & their regulatory bodies    
  • Maintain regular communication channel to keep teams apprised of the status of submission publication activities    
  • Gain clear understanding of submission ready requirements and develop a good working knowledge of all tools/systems used in support of publishing processes    
  • Management of individual workload. 

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Continuous improvement     

  • Participate in knowledge sharing across Kinapse Operations Team members    
  • Input into all Kinapse and Client publishing services quality and tracking systems    
  • Demonstrate constant attention to detail to ensure each submission package is correct and in the required format and delivered in a timely manner to expedite publication.  

Quality management     

  • Actively participate in performance management initiatives such as periodic performance reviews/appraisals and where necessary assist with the training of new colleagues. Work closely with the Operations Team Leader/Senior Publisher to identify support and guidance training/coaching requirements. Offer support & guidance to other team members where possible once training is complete    
  • Ensure all individual contributions to team deliverables have been quality checked in line with Client expectations before peer hand-off.

Candidate Profile :

  1. 2 to 5 years of experience in publishing of eCTD, NeeS and Paper submissions using various publishing tools    
  2. Life sciences degree desirable but not essential    
  3. Experience of working in operational publishing teams    
  4. Experience in Documentum-based dossier repositories. 

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Expertise required     

  1. Compliance checking, linking, Bookmarking, QC/ review of documents, Rendering Multiple Documents to PDF, Creation of external links, 5 in eCTD format.    
  2. Compilation of NeeS, Compilation of paper submission, QC/ review of dossier, Publishing & Validation    
  3. Good working knowledge of less complex tools/systems used in support of publishing processes, in particular eCTDXpress, ISIPublisher, ISIToolbox, Compose etc.    
  4. Good communication skills (both written and verbal)    
  5. Ability to prioritise and multi-task a number of projects     Integrity, credibility, and commitment to building the success of the Kinapse-Client partnership    
  6. Good understanding of existing regulatory agency standards and formats for submission and ensure that the CMC publishing output meets these requirements    
  7. Good knowledge of ICH/ regional eCTD guidelines

Additional Information:
Experience : 2-5 years
Qualification : Life sciences degree
Location : Bangalore, Gurgaon,
Industry Type :  Pharma / Biotech / Clinical Research
Functional Area : Regulatory Affairs
Last date : 25th August, 2016

To apply, email your CV to recruitment@kinapse.com

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