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
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
Competitive salary according to experience and knowledge Life and medical insurance Constant training Opportunity for growth and development
Send Your Resume to: hectorfernando.ramir@hcl.com
HCL Technologies hcl.com
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