Senior Medical Writer – India

Celegence is seeking a Senior Medical Writing Specialist to join our consulting team in support our expanding list of Medical Device clients. The consultant will be responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.

Roles & Responsibilities

  • Practices good internal and external customer service
  • Responsible for scientific medical writing and producing high quality documents
  • Demonstrates strong understanding of ICH guidelines, as applicable to medical writing
  • Creates medical writing training exercises, trains new medical writers, and serves as a mentor
  • Trains via self-study and self-practice independently and explores advanced topics related to medical writing and/or drug development
  • Excellent understanding of MS Word for advanced writing techniques
  • High proficient with styles of writing for various document types
  • Expert proficiency with client templates & style guides
  • Interacts directly and independently with client to coordinate all facets of projects; competent communicator
  • Highly competent review of blinded data tables, listings, and graphs for study report writing
  • Writes documents independently, with skill and proficiency
  • Addresses client comments during document lifecycle, including critical review of comments and value-added suggestions
  • Assumes responsibility for quality and integrity of documents
  • Independently implements and validates QC findings in compliance with NC Handling Procedure
  • Conducts thorough review of his/her documents prior to release to client; serves as high level reviewer for documents produced by his/her colleagues
  • Follow processes related to project management processes as appropriate for medical writing projects
  • Demonstrates extensive knowledge of departmental processes
  • Takes initiative to suggest and implement departmental process improvements
  • Leads some projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
  • Develops excellent internal and external leadership skills for projects
  • Complies with Document and Record Control Procedure
  • Ensures compliance to applicable policies and procedures

Education & Experience

Education:

  • Bachelor’s Degree / Post Graduation in any relevant Life Sciences fields. Master’s Degree is preferred

Experience:

  • Minimum 5-7 years of relevant Medical/ Scientific writing required
  • Familiar with the Life Sciences Industry, preferably Regulatory Services
  • Experience in performing medical literature searches (PubMed, Google Scholar, etc.)
  • Hands on experience on presentation tools like PowerPoint, Visio etc will be an added advantage
  • Strong hands-on experience with clinical trials and pharmaceutical development in the pharmaceutical or CRO industry
  • Ability to work independently

Skills and Competencies

Technical / Functional Skills:

  • Experience with the core medical /scientific writing activities and knowledge of protocol, CSR, IB, eCTD and regulatory requirements
  • Has high level knowledge of drug development as pertains to medical writing; has the ability to apply drug development knowledge during production of high quality documents
  • Excellent medical/scientific writing skills
  • Experience with document templates and style guidelines such as AMA, QRD
  • Strong resource for medical/scientific writing; willing to guide others in a variety of authoring and reviewing techniques
  • Proficiency with MS Office applications

Non-Technical Skills:

  • Possess strong verbal and written communications skills, interpersonal skills, strategic thinking, ability to influence others & problem resolving skills
  • Client focused approach to work
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize and manage multiple projects
  • Familiarity with ISO 9001:2008 requirements

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Please make sure you have the relevant work visa prior to applying

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