Associate - Scientific Writing

1 week ago

Bengaluru Karnataka, India Indegene Full time

**Date**:20 Sept 2025

**Location**:Bangalore, KA, IN
- Job Description-
- Must Have-
**Responsibilities**:

- Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
- Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
- Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.
- Responsible to participate in assigned training programmes relevant to the job.
- Work and interact extensively with clinical and regulatory experts, 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.
- Interface with clients on a regular basis to meet their expectations.
- Orientation Compliance to quality, confidentiality and security.
- Adhere and follow quality systems, processes and policies.
- Comply to training and specifications.

Qualifications:

- Medical/M.Pharm/Pharm D/life sciences degree.

Your impact:
About you:

- Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in end to end authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports

Must have:

- Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
- Excellent written and verbal communication skills.
- Excellent organizational and time management skills.
- Excellent data interpretation and presentation skills.
- Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.

Nice to have:

- Strong interpersonal skills and the ability to be flexible in varying environments
- Good mentoring skills.

Good to have- EQUAL OPPORTUNITY

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