Manager Medical Writing required vacancy @ Indigene, Banglore, D 5

Job description

Position Details : Manager Medical Writing

Designation : Manager Medical Writing

Experience : 3 to 5 years

Position Type : Full Time

Functional Area : Scientific Content

Education : B.D.S, MBBS, Ph.D

Work Location : Bangalore

Job Description 

1. Should be accountable for the quality, implementation, and timeliness of medical writing
deliverables, including clinical study reports (phases I–IV), clinical study protocols,
safety narratives, investigational drug brochures, summaries of efficacy and safety,
PSURs, scientific manuscripts, and abstracts

2. Work and interact extensively with clinical and regulatory experts, biostatisticians
as well as external contacts to ensure high quality with regard to scientific
content, organization, clarity, accuracy, format, and adherence to regulatory
and internal guidelines, styles, and processes

3. Provide guidance and support to all team members on a project with
regard to format, style,content, and compliance

4. Ensure that clinical documents adhere to current global standards,
FDA, ICH, and GCP guidelines and are in accordance with
electronic publishing standards

5. Guide and mentor team members to ensure consistency and completeness
of the project

6. Provide peer review for colleagues' documents

7. Create, maintain, and disseminate medical writing training materials and
guidelines, and conduct training seminars as necessary

8. Write SOPs and/or review them for completeness and updates as needed

9. Review and write clinical proposals and project status report

Desired Profile
1. Able to demonstrate thorough knowledge of FDA, ICH, and GCP
guidelines regarding thesubmission of documents in accordance
with current regulatory standards

2. Must have proven experience (minimum 4–5 years) as a scientific medical
writer in a clinical research environment and proven experience in the
management of medical documentation

Soft Skills 

· Client focus

· Result orientation

· Communicating with Impact

· Team player

· Process oriented

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