Job Description

1.Medical Writing Maintains diverse clinical documents, manage the writing, editing and reviewing and finalisation

• Clinical document writing : Ability to manage the writing, editing and reviewing of diverse clinical documents including clinical study reports (CSRs), clinical trial synopses, study protocols, investigator brochures, informed consent forms, clinical data summaries, including SOPs.
• Core writing and review skills: Possesses the knowledge to manage the writing, editing and reviewing of, publications, abstracts, manuscripts, Posters.
• Regulatory Skills: Exhibits knowledge around the applicable guidance's , style guides, regulations from the respective writing assignments towards ensuring quality delivery.

2.Clinical Research Methodology Ensures clinical documents according to appropriate SOPs, enhance therapeutic area knowledge, understanding of experimental methods etc

• Clinical document management: Ensure that all clinical documents are produced according to appropriate SOPs, business practices and quality standard
• Scientific knowledge : Ability to develop and enhance therapeutic area knowledge, understanding of experimental methods, research design and statistical analysis

3.Stakeholder Management Work with diverse stakeholders, consensus on decision making for a document finalization and sign off.

• Stakeholder management : Demonstrates the skill to effectively work with diverse stakeholders - clinical sc. Scl. Ops. Med ops, biostatistics, PV etc. and PD
• CRO Management : External co ordination with CROs and other vendors
• Facilitate self in the role of a medical writer-integrator role to bring consensus on decision making for a document finalization and sign off.

4.Continuous Improvement Knowledge based learning and improvisation both in terms of content, process and tools enablining efficient, timely and quality delivery

• Writing Skills as per the new methodoly and guidances : Continous improvement and enhancement of writing skills, familiarisation and adoption of newer methodologies and guidances

5.Digital capability Exhibits knowledge and understanding of digital systems

• Daily operational tool management : well versed with all styleguides, MS office, Adobe toolkit