We are hiring Senior Medical Writer III (Contract to Hire).
Please let me know if you are interested or anyone who might be interested.
Client: Major Pharmaceutical Client
Position: Senior Medical Writer III (Contract to Hire)
Duration: 12 Months Contract
Location: Vishweshwariah Nagar, Bangalore 560032
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DESCRIPTION:
***THIS IS A HYBRID ROLE***
Primary Function of Position:
This contract-to-hire Medical Writer position reports to Sr. Manager, Medical Sciences and requires a strong candidate with significant experience in medical writing of Clinical Evaluation Reports per applicable regulatory requirements, in support of regulatory submissions as well as ongoing updates to maintain regulatory conformance. Potential for future additional responsibility includes authoring other clinical and regulatory documents as well as abstracts and manuscripts for publication. The position will work with the in-house team and support the writing and review of these documents.
Roles and Responsibilities:
- Authoring clinical documentation mainly the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER), including clinical sections of regulatory authority requests
- Authoring sections of other clinical documents such as the Clinical Literature Analysis Report (CLAR), Clinical Study Report (CSR), Annual Progress Report (APR), Clinical Study Protocols, and Investigator Brochures (IB)
- Acquiring knowledge of therapeutic areas, literature review processes, and the ability to keep abreast of current literature
- Participating in and/or performing comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support clinical activities and related clinical studies, and to stay informed about applicable clinical landscapes and trends
- Working with the clinical librarian to support literature searches
- Reviewing scientific literature and critically appraising, analyzing, and writing clinical summaries for medical and surgical procedures
- Writing abstracts and developing posters for conference presentations, and writing and reviewing manuscripts for publication
- Proofreading, editing, inserting and formatting references, document formatting, review comment integration, and document completion/approval activities
- Ensuring compliance with corporate requirements (e.g., SOPs) and regulatory requirements (e.g., GCP and applicable guidelines)
Skill / Job Requirements:
- Minimum of 4+ years of medical writing experience
- 1+ years of experience in clinical evaluation report writing in the medical device industry is preferred
- Previous experience applying therapeutic and device knowledge to support the development of clinical evaluation reports
- Strong experience conducting literature searches, reviewing, appraising, and interpreting scientific data
- Demonstrated ability to clearly and effectively communicate verbally and through technical or scientific writing; excellent scientific writing skills
- Excellent critical and analytical thinking skills
- MD, PhD, or M.S. degree in a scientific field is desired
- High level of attention to detail and accuracy
- Ability to work effectively with internal team members
- Ability to manage multiple projects across multiple surgical disciplines
- Strong communication, presentation, interpersonal, project management, and organizational skills
- Ability to learn quickly and self-educate on different surgical specialties as applicable (self-starter attitude)
- Consistently demonstrates dedication and strong work ethic to meet aggressive timelines and manage multiple writing projects when necessary
Regards
Vishnu Das Natesan
[Confidential Information]
