Clinical Medical Writer
Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process.
Combining deep transparency expertise with a modern technology stack, Xogene also provides software solutions to automate processes and track myriad studies, regulations and statuses.
Our expertise ranges from clinical trial registration and results reporting, medical writing, document redaction and lay summary development, to SAS/XML support, data sharing, online study tracking solutions, and building/hosting websites.
Xogene is headquartered in New Jersey with offices in Vienna, Austria and Gurgaon and Pune, India. As a fast growing, dynamic company, we are looking to grow our team with self-motivated, experienced medical writers and SMEs who are highly detail-oriented and organized with great communication skills. In return for the hard work and commitment to excellence from the team, Xogene offers a dynamic and meritocratic environment with great benefits and flexibility.For more information, visit us at http://www.xogene.com.
Responsible for the writing of documents containing scientific data pertaining to multiple, complex clinical research and medical affairs projects.
KEY TASKS AND RESPONSIBILITIES:
- Develop/write clinical documents for submission (especially investigator brochures, protocols, clinical study reports, post-study documents such as ISS, ISE, Clinical Summaries, Clinical Overview), ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
- Oversee development/writing of clinical documents for submission (especially protocols, CSRs) by external service providers, ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
- Provide key messages on the interpretation of clinical study results to external service providers for the development of clinical documents such as CSRs.
- Ensure compliance of clinical documents with national and international regulatory agency regulations/guidelines and departmental standard operating procedures.
- May write/review/prepare briefing books, product labels, and responses to regulatory agencies’ inquiries regarding products to support franchises.
- Work closely with clinical teams on assigned projects to ensure adherence to timelines.
- Ensure that all compositions conducted under his/her/their responsibility are performed within time, quality and cost expectations and in a manner that is both ethically and legally acceptable to all regulatory agencies.
- Advance Degree in Medicine, Pharmacology, Biology or related scientific discipline; Masters degree preferred
- 3+ year(s) clinical medical writing experience or scientific writing with a pharmaceutical or biotechnology company or a contract research organization
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
- Understanding of FDA/EMA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production (including CTDs)
- Expertise in analytical evaluation of scientific data, organizational skills, and the ability to work in a team environment
- Knowledge of plasma derived therapeutic areas (products and therapies) or related scientific areas
- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
- Strong computer skills with Microsoft Word, Excel, PowerPoint and Adobe (or any other PDF-related program)
- Meticulous attention to detail
- Intercultural understanding with a global perspective