Spurthi Bethapudi

An astute professional with about 6 years of diversified experience in authoring and quality control review of various regulatory documents (especially Protocols, Informed Consent Forms [ICFs], Risk profiles, Investigator Brochures, and patient narratives) and scientific documents (abstracts & posters).

Senior Medical Writer - Syneos Health

(2022-05)

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but not limited to: Clinical study protocol amendments and addenda, Patient narratives, Investigator brochures, Risk profiles, Abstracts, Poster and oral presentations
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• 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 providing review comments on draft and final documents.

Medical Writer II - Syneos Health

(2021-02 - 2022-04)

• 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: Patient narratives, Investigator brochures
• 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.

Masters - Pharmacy-PAQA - JNTU, Hyderabad, TG (2013 - 2015)

Bachelors - Pharmacy - Gokaraju Rangaraju college of pharmacy (2009 - 2013)