Puesto:
Medical Writing – Reviewer
Descripción del trabajo:
RESPONSIBILITIES
The medical writing reviewer collaborates with members of cross-functional teams in the preparation of clinical documentation within agreed-upon timelines. The reviewer conducts a thorough review of the clinical documentation with respect to Good Clinical Practices (GCP) in order to maintain the highest level of quality and compliance.
POSITION SUMMARY
Primary role:
• To perform tasks including literature search, summarizing and analyzing data from clinical studies for medical devices
• Review of medical journals and technical reports
• Working closely with clinicians, researchers and other medical services personnel to provide information which is accurate and easy for others to understand
RESPONSIBILITIES
• Reviews literature articles and extracts relevant information
• Highly knowledgeable and experienced in the regulatory medical writing process
• Suggests or identifies modifications, changes, and improvements to the document preparation procedures and templates in order to improve efficiency, quality, and productivity
• Provides a structured focus for writing content (task, concept, reference, and troubleshooting)
• Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensures that appropriate documented quality control checks are performed on medical writing deliverables and recommends process improvements
• Enhances the quality of clinical documentation through reasoning and presentation
• Facilitates technical discussions with clinical evaluators and customer therapeutic area experts
• Provides training to the medical writing team related to process, amendments, and recent market updates
Requisitos:
Skills:
• Effective communication skills that include the provision of timely and accurate information to stakeholders, strong written and oral communication skills, computer literate: MS Office
• Attributes: Self-motivated and motivational, self-starter, positive team player.
• Proficient in Microsoft Office® (Word, Excel, PowerPoint)
• Strong working knowledge of technical and regulatory writing requirements and experienced in the review of technical documents
• Ability to evaluate and analyze technical information
• Knowledge of Good Clinical Practices (GCP) and other relevant regulations, standards, and guidance related to medical devices
Qualification:
• Any Master's or Bachelor's degree in Life Sciences, biomedical engineering
• Basic understanding of human anatomy and physiology is preferable
• Knowledge of disease pathology and their treatment is an advantage
• Knowledge of Medical device regulations is preferable
• 5-6 years of relevant work experience recommended
Salario:
Competitive salary according to experience and knowledge
Life and medical insurance
Constant training
Opportunity for growth and development
Contacto:
Send Your Resume to: hectorfernando.ramir@hcl.com
Empresa:
HCL Technologies hcl.com
Fecha de publicación: