Medical Writing II (Syneos Health, Pune)
✍️ Unlock Your Potential: Medical Writing II at Syneos Health in Pune! 🇮🇳
Are you a seasoned medical writing professional looking for your next exciting opportunity? Syneos Health is seeking a talented individual to join their team as a Medical Writing II, focusing on CSR Narratives and Quality Control review! This role offers a chance to be part of a leading biopharmaceutical solutions organization dedicated to accelerating patient success and fostering a supportive work environment.
🗓️ Updated: June 27, 2025
📍 Location: Pune, MH, India
🆔 Job ID: 25000321
About Syneos Health 🌟
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. They translate unique clinical, medical affairs, and commercial insights into real-world outcomes. With a patient-centric Clinical Development model, they strive to simplify and streamline work, making them an ideal partner and employer. They are passionate about changing lives and dedicated to developing their people through career progression, supportive management, training, peer recognition, and a comprehensive total rewards program. Syneos Health cultivates a "Total Self" culture that embraces diversity and ensures everyone feels a sense of belonging.
Their Impact: Over the past 5 years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites with more than 675,000 trial patients!
The Role: Medical Writing II (CSR Narrative, QC review) 📝
This pivotal role involves meticulous medical writing with a strong emphasis on Clinical Study Report (CSR) Narratives and thorough Quality Control (QC) review.
Key Responsibilities ✨
As a Medical Writing II, you will:
* Guide and mentor less experienced medical writers on projects.
* Compile, write, and edit medical writing deliverables across various departments with minimal supervision.
* Develop crucial documents such as Clinical study protocols and amendments, Clinical study reports, Patient narratives, Annual reports, and Investigator brochures.
* Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency.
* Collaborate with data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality deliverables.
* Serve as a peer reviewer, ensuring scientific content, clarity, and consistency.
* Adhere to regulatory standards (ICH-E3 guidelines), Company SOPs, and client standards, ensuring timely project completion within budget.
* Conduct online clinical literature searches.
* Stay updated with the drug development process, regulatory guidelines, and client expectations.
* Manage project budgets and complete administrative tasks efficiently.
* Minimal travel (less than 25%) may be required.
Qualifications You Bring 🎯
To excel in this role, you should possess:
* A minimum of 3 years of medical writing experience, with at least 3 years specifically in Narrative writing.
* Proven expertise in independent authoring and reviewing CSR Narratives.
* A Bachelor of Science degree with relevant writing experience, or a Bachelor of Arts degree (Social Sciences, English, or Communications preferred) with relevant scientific/medical knowledge.
* Extensive knowledge of English grammar, FDA and ICH regulations and guidelines, and familiarity with AMA style guide.
* Demonstrated independence, strong presentation, proofreading, interpersonal, and leadership skills, fostering a team-oriented approach.
* Proficiency in Word, Excel, PowerPoint, email, and Internet.
* Ability to understand principles of clinical research and interpret complex clinical data.
If you are ready to make a significant impact in the biopharmaceutical industry and grow with a dynamic company, explore this opportunity at Syneos Health!
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