Practices good internal and external customer service
Responsible for scientific medical writing and producing high quality documents
Understands ICH guidelines, as applicable to medical writing for clinical studies
Creates medical writing training exercises; mentors new medical writers
Trains via self-study and self-practice independently and explores advanced topics related to medical writing and/or drug development
Strong understanding of MS Word for advanced writing techniques
Proficient with styles of writing for various document types
Strong proficiency with client templates & style guides
Interacts directly and independently with client and demonstrates strong client interaction skills
Complete competence reviewing blinded data tables, listings, and graphs for study report writing
Writes documents without oversight
Addresses client comments during document lifecycle, including critical review of comments and value-added suggestions
Assumes responsibility for quality and integrity of documents
Independently implements and validates QC findings in compliance with NC Handling Procedure
Conducts thorough self-review of deliverables prior to release to client; serves as high level reviewer for others
Follows processes related to project management as appropriate for medical writing projects (e.g. updating PSS etc.)
Participates in improvements to departmental processes and recommends efficiencies
Demonstrates internal and external leadership skills for projects with minimal management oversight
Complies with Document Control Procedure Complies with Record Control Procedure
Ensures compliance to applicable ISMS policies and procedures
Job Requirements (Minimum Education / Experience / Training / Skills)
College graduate in scientific, medical, clinical discipline or related field, or related experience
Has high level knowledge of drug development as pertains to medical writing; has the ability to apply drug development knowledge during production of high quality documents
Hands-on experience with clinical trials and pharmaceutical development
2-6 years writing experience in the pharmaceutical or CRO industry preferred
Skilled in the writing of various documents
Excellent scientific writing skills
Understands scientific, medical, and/or clinical data
Proficiency with MS Office applications
Excellent organizational and communication skills Familiarity with ISO 9001:2008 requirements
Job Classification
Industry: Pharma / Biotech / Clinical Research, Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category: Drug Regulatory Affairs/Documentation Role: Drug Regulatory Affairs/Documentation Employement Type: Full time
Education
Under Graduation: Any Graduate in Any Specialization Post Graduation: Post Graduation Not Required Doctorate: Doctorate Not Required