Looking For Medical Writer - Clinical who Can join us Immediately

Qualification(s)

Degree in lifesciences / B.Pharma / M. Pharma

Experience(s)

• 2 to 4 years of prior medical writing experience preferred; Interested in expanding his/her knowledge of drug development as it pertains to medical writing/labelling activities
• Experience in the pharmaceutical or CRO industry preferred

Technical Skills

• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge
• Good scientific writing skills and understanding of ICH requirements
• Proficiency with MS Office applications and style guides for writing various document types
• Experience in writing CSRs, Labelling documents, Investigator Brochures (IB), summary of changes (SOC), proposed prescribing information (PPI), DSURs / PSURs / PADER/PBRERs, safety narratives, risk management plans (RMP)

Soft Skills

• Excellent English written and verbal communication skills
• Good organizational, interpersonal and communication skills

Competencies

• Good knowledge of industry regulations and compliance requirements applicable to pharma/life sciences
• ICH Guidelines and eCTD knowledge

Personal Traits

• Good planner and Skilled communicator
• Well organized to work independently with minimum oversight

Roles and Responsibilities

• Responsible for scientific medical writing and producing high quality documents
• Analyze source documents and create, edit and manage the production of high quality clinical and Non-clinical documents such as CSRs, Labelling documents, Investigator Brochures (IB), summary of changes (SOC), proposed prescribing information (PPI), DSURs / PSURs / PADER/PBRERs, safety narratives, risk management plans (RMP) documents
• Works with other writers for developmental purposes and writes documents with little oversight, as applicable
• Reviews deliverables with little oversight prior to releasing to client.
• Develops competence reviewing blinded data tables, listings and graphs for study report writing
• Addresses client comments during document lifecycle; manages expert/scientific reviews and revisions; performs clean reads
• Learns to independently implement and validate QC findings as per agreed procedure
• Understands ICH and other guidelines towards medical writing/labelling activities, maintaining knowledge of the current regulations and upcoming changes
• Practices good internal and external customer service
• Develops project coordination skills
• Participates in improvements to departmental processes
• Develops internal and external leadership skills
• Understands and begins to follow processes related to project management as appropriate for medical writing/labelling projects
• Complies with document and record control procedure
• Ensures compliance to applicable IQMS policies and procedures
• Maintain and enhance knowledge of regulatory guidelines and publication guidelines.