Join Navitas Life Sciences: Medical Writer Opportunity in 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.

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.