Join Navitas Life Sciences: Medical Writer Opportunity in Manipal

Join Navitas Life Sciences Medical Writer Opportunity in Manipal
  • Full Time
  • Manipal

Medical Writer Opportunity at Navitas Life Sciences, Manipal

Navitas Life Sciences, a global clinical research organization, is seeking experienced candidates for the role of Medical Writer. With over 1000 employees and a presence in 5 countries, Navitas Life Sciences is committed to accelerating the time to market for life-saving therapies. If you are passionate about contributing to the drug development process and have a strong background in medical writing, we invite you to explore this exciting opportunity.

About Navitas Life Sciences

Location: Udupi Taluka, Karnataka, India
Headquarters: Princeton, NJ
Website: www.navitaslifesciences.com

Navitas Life Sciences is a technology-backed CRO providing end-to-end and point services for drug development. With a focus on technology-driven solutions, the organization offers outsourced data science, regulatory & safety, and full-service CRO services. Navitas Clinical Research and Navitas Data Sciences are integral parts of the organization, delivering comprehensive clinical research and clinical data functional services globally.

Job Opening: Medical Writer

Experience: 5 to 8 years
Location: Manipal

Job Description:

As a Medical Writer at Navitas Life Sciences, your responsibilities will include:

  • Preparation of Clinical study protocols and CSRs for Phase I and BA/BE studies in adherence to SOPs, study objectives, regulatory requirements, and ICH guidelines.
  • Review of guidance documents and scientific literature to conceptualize clinical study design and methodology.
  • Collaboration with cross-functional teams including Clinical Pharmacologists, Statisticians, and Research Scientists for study outlines and protocol summaries.
  • Coordination with various teams for the preparation of CSRs, study Protocols, and Informed Consent Forms.
  • Handling amendments, addendums, errata, and version history updates as per SOPs and regulatory requirements.
  • Preparation of responses to Sponsor and Regulatory Queries.
  • Revision and updating of SOPs related to Medical Writing Department-BA/BE.
  • Imparting training to staff on relevant SOPs and participating in Departmental Training Programmes.
  • Allocation of tasks to team members and ensuring timely completion.

Skills and Knowledge:

  • Knowledge in BA/BE clinical studies.
  • Familiarity with ICH-GCP guidelines.
  • Understanding of Regulatory guidelines such as CDSCO, USFDA, EMEA, WHO, etc.
  • Strong oral and written communication skills.

How to Apply:

If you meet the qualifications and are excited about joining our dynamic team, please share your CV with us at praneetha.krishna@navitaslifesciences.com.

Join Navitas Life Sciences Medical Writer Opportunity in Manipal
Join Navitas Life Sciences Medical Writer Opportunity in Manipal

Navitas Life Sciences is an equal opportunity employer, and we encourage candidates from diverse backgrounds to apply. Join us in making a difference in the world of clinical research and healthcare.

To apply for this job please visit navitaslifesciences.com..

🌟 Calling All Network Members! 📚👥 Share the Knowledge!🚀 Contribute to our website! Share jobs, study materials, interview Q&A, and academic project files.contribute here: https://pharmastuff.org.in/job-posting/