- Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
- Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
- Perform review to validate accuracy and relevance of the data presented in all 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 junior writers with incorporation of review comments, tracking and communication. Assist and mentor colleagues on the scientific formats required to prepare the documents, to ensure consistency and completeness of the report, provide guidance and support with regard to format, style, content, and compliance.
- 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.
- Responsible for continuous process improvement in the team for developing content.
- 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.
- Create, maintain and disseminate training materials and guidelines and conduct training seminars as necessary.
- Control/reduce effort, cycle time and error rates in projects.
- 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.
- Provide peer review for colleagues in support of all documents.
- 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.
- Medical/ D/life sciences degree.
- Minimum 3 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
- Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
- Good knowledge of document management systems and other relevant applications ( Excel, Outlook).
- 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.
- Strong interpersonal skills and the ability to be flexible in varying environments
- Good mentoring skills.
Senior Associate - Bengaluru, India - Indegene
Description
Title: Senior Associate - Scientific Writing
Date: 20 Mar 2024 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
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.
If this excites you, then apply below.
Senior Associate - Scientific Writing
Job Description:
We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team The successful candidate will be responsible for authoring/performing QC/review of safety documents.
Responsibilities:
Qualifications:
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:
Must have:
Nice 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, 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.