Medical Writer

2 days ago

Bengaluru, India MMS Full time

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 mínimal 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
- 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
- Excellent organizational and communication skills - Familiarity with ISO 9001:2008 requirements

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