Medical Writer I / Medical Writer II, CSR Narratives

This is a fully remote position, open to applicants in India.

📋 Description

• Provide mentorship to junior medical writers on various projects as needed.

• Gather, compose, and refine medical writing deliverables with limited oversight.

• Create or assist in the development of clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures.

• Assess statistical analysis plans and table/figure/listing specifications for accuracy, grammar, formatting, and consistency.

• Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams to generate writing deliverables.

• Act as a peer reviewer, addressing team feedback regarding scientific content, clarity, consistency, and formatting.

• Adhere to ICH-E3 guidelines, company SOPs, client standards, and approved templates while ensuring timely and budget-conscious project completion.

• Conduct online searches of clinical literature as needed.

• Pursue ongoing professional development related to regulatory guidance and client requirements.

• Monitor project budget parameters and relay any changes to medical writing leadership.

• Fulfill necessary administrative responsibilities and undertake other assigned tasks.

• Travel infrequently when necessary (less than 25%).

⛳️ Requirements

• At least 1 year of experience in narratives with a master's degree, or 2 years of experience with a bachelor's degree.

• Postgraduate (Masters / Mpharm) or bachelor's degree.

• Strong experience in drafting and assessing narratives.

• Comprehensive knowledge of English grammar, FDA and ICH regulations and guidelines, along with familiarity with the AMA style guide.

• Effective skills in presentation, proofreading, interpersonal communication, and leadership.

• High proficiency in Word, Excel, PowerPoint, email, and Internet applications.

• Understanding of clinical research principles.

• Capability to interpret and present clinical data and complex information.

• Familiarity with the drug development process and regulatory guidelines.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Minimal travel requirements (less than 25%).