Indegene Associate – Scientific Writing Job – Apply Online
Title: Associate – Scientific Writing
Date: 13 Dec 2023
Location: Bangalore, KA, IN
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com
Introduction
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it? We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting
for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.If this excites you, then apply below.
Job Title: Associate – Scientific Writing
Job Description:
We seek an ambitious and energetic Medical Writer to join our Safety team! The successful candidate will be responsible for authoring/preparing submission readiness/QC of regulatory/safety documents.
Responsibilities:
- Responsible for authoring, incorporation of review comments, tracking, communication and coordinating with QC process, submission-readiness activities of simple and medium complexity documents.
- Discuss project details and obtain clarification on specific questions/issues/gaps with project POC.
- Perform peer review to validate accuracy and relevance of the data presented in the documents against the source data or references used in the document.
- Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data (text/number) within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style).
- Assist senior medical writers in authoring medium/complex deliverable types.
- Obtain references from library and link to the document.
- Formatting word documents as per the client-specific style guide – creation of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, endnotes and cross referencing.
- Formatting PDF documents in Adobe Acrobat and ISI Toolbox, cross referencing, pagination, bookmarking and hyper-linking.
- Perform reference request task.
- Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
- Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards.
- Responsible to participate in assigned training programs relevant to the job.
- Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest.
- Interface with clients on a regular basis to meet their expectations.
- Compliance to quality, confidentiality and security.
- Adhere and follow quality systems, processes and policies.
- Comply to training and specification.
Qualifications: Medical/M.Pharm/Pharm D/life sciences degree.
If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
About you:
- Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain.
- Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
- Knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
- Good written and verbal communication skills.
- Good organizational and time management skills.
- Good attention to detail and decision-making skills.
- Strong interpersonal skills and the ability to be flexible in varying environments (Nice to have)
- Willingness to collaborate and work in teams (Nice to have)
Indegene Associate Scientific Writing
