Medical Writer

Job Description:

Responsibilities

•  Mentors less experienced medical writers on projects, as necessary.
•  Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.
•  Develops or supports a variety of documents that include but not limited to:
•  Clinical study protocols and clinical study protocol amendments;
•  Clinical study reports;
•  Patient narratives;
•  Annual reports;
•  Investigator brochures.
•  Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
•  Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
•  Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
•  Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
•  Performs on-line clinical literature searches, as applicable.
•  Working knowledge of drug development process and regulatory guidelines.
•  Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.
•  Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
•  Completes required administrated tasks within the specified timeframes.
•  Performs other work-related duties as assigned.
•  Minimal travel may be required (less than 25%).

Qualification & Experience

• Should have Min 1 years of experience working in narratives. Must have good experience in drafting and reviewing narratives.
•  Should be a Postgraduate (Masters /Mpharm ) or bachelor’s degree.
•  Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.