Novo Nordisk Medical Writer Vacancy 2021 - Apply Online

Novo Nordisk Medical Writer Vacancy 2021 – Apply Online

Novo Nordisk is looking for a Senior Medical Writer in Global Development (GD) unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.

Location Bangalore, India

Job category Clinical Development and Medical

Job Title: Medical Writer

Qualifications

  • You need to have the below knowledge and skills.
  • Graduate (Ph.D., MSc., M Pharm, or equivalent)
  • 3+ years of experience as a medical writer or other relevant work experience
  • Experience with a broad range of different medical writing tasks
  • Experience working within a global setting
  • Strong understanding of external requirements related to regulatory documents
  • Experience from the pharmaceutical /CRO industry

Relevant experience with drug application processes to FDA and EMEA

You should Work independently on smaller tasks, have strong analytical skills, should be committed, persistent and accountable, be able to manage variable workload, able to handle numerous tasks simultaneously, recognize problems; may need the advice to solve, should prioritize your own tasks but may need to seek advice.

You should be able to plan and coordinate complex medical writing tasks, systematic, organized, open, and

honest. You should have good communication skills, be a good team player, be able to relate to other people in a multinational environment, be fluent in written and spoken English, be good at providing support and training to others.

You should communicate with integrity, should have negotiation skills, good knowledge of the therapy area.

The Position

  • As a Medical Writer, you are responsible for Trial Medical Writing, Project Medical Writing and/or responsible for non-trial activities within clinical reporting, coaching, and mentoring other medical writers including training. You contribute to knowledge sharing and good collaboration with stakeholders and colleagues worldwide.
  • You are responsible for CTR, Layperson summary, IB, PIP/PSP, Regulatory response documents (Q&A), Variation applications – clinical summary and overview documents in CTD/eCTD format for regulatory submissions, meeting requests, meeting packages, abstracts, manuscripts, Q&A slides for AdComm, meeting presentations, posters, Protocol outline, protocol, SI/IC, other documents required.
  • You contribute to clinical summary and overview documents in CTD/eCTD format for regulatory submissions, briefing book, market access dossier documents. You review PSPS, SPS, SAP, Statistical output / TFL. You contribute to Fora, M&S team, PPG, improvement project or other cross-functional teams, clinical submission team. You should be an SME.
  • You coach and mentor for support MWs, you are responsible for training other associates and contributing to training materials/workshops. You maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas, actively participate in relevant meetings, training sessions and seminars in the department, competency anchor and relevant project(s), contribute to knowledge sharing and sharing best practices.
  • You ensure timely, clear and proactive communication with stakeholders and colleagues for effective interactions and collaboration.

Apply Online

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