MMS Hiring Safety Writer
5 May, 2022
Roles and Responsibilities
- Responsible for writing safety documents intended for submission to regulatory agencies.
- Responsible for writing patient CSR narratives and producing high quality documents
- Practices excellent internal and external customer service
- Good understanding of MS Word for advanced writing techniques
- Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client
- Ensure documents comply with appropriate ICH and regulatory guidelines
- Interact directly and independently with client
- Ability to follow MMS and sponsor processes
- Practices internal and external leadership skills
Job Requirements (Minimum Education / Experience / Training / Skills)
- Experience in CSR narratives and aggregate reports
- University graduate in scientific, medical, clinical discipline or related field, or related experience
- Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
- Master’s or PhD in a scientific, medical, or clinical discipline preferred
- Min 4 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment
- Understands ICH guidelines, as applicable to medical writing for clinical studies
- Excellent written English skills
- High degree of organization and able to manage multiple projects at any given time
- Attention to detail and committed to excellence in all aspects of their work
- Excellent communication and interpersonal skills
- Proficient in Microsoft Word and Adobe Acrobat
- Experience in the use of an Electronic Document Management system
Apply through this Link
I am Aleena Thomas working in Intas Pharmaceuticals as a Medical Trainer.
I have done my M.Pharm in Pharmacology. I have 1.2 yrs experience in CRO as a Clinical Research Coordinator.
I am interested in medical writing profile. Kindly consider. looking for a job at Pune region.
Mob No. 6359618511