Title:  Associate - Scientific Writing

Job Description

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 Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

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 programmes relevant to the job. � Volunteer in training programmes 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. Your impact: About you: � Minimum 2 years� experience in medical writing or equivalent experience in life sciences domain. Must have: � 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. Nice to have: � Strong interpersonal skills and the ability to be flexible in varying environments � Willingness to collaborate and work in teams

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.