Medical Writer II (QC of Regulatory Docs) Syneos Health

2.0 - 6.0 years

0 Lacs

haryana

On-site

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,

Posted 2 days ago

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Medical Writer II (Narrative Writing) Syneos Health

2.0 - 6.0 years

0 Lacs

haryana

On-site

The position of Medical Writer II (Narrative Writing) at Syneos Health involves compiling, writing, editing, and coordinating medical writing deliverables that clearly and accurately present scientific information. Working within and across departments with minimal or moderate supervision, the Medical Writer completes various documents such as clinical study protocols, patient narratives, investigator brochures, informed consents, journal manuscripts, and presentations for scientific meetings. Adherence to established regulatory standards, including ICH E3 guidelines, company SOPs, and client standards is crucial to ensure timely and budgeted completion of medical writing projects. Key responsibilities of the role include coordinating quality and editorial reviews, managing source documentation, acting as a peer reviewer for internal teams, reviewing statistical analysis plans, and interacting with clients and peers to produce high-quality writing deliverables. The Medical Writer mentors less experienced writers, maintains a strong knowledge of drug development processes and regulatory guidelines, and performs online clinical literature searches while complying with copyright requirements. The ideal candidate for this role should hold a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and extensive knowledge of English grammar are essential. Additionally, the candidate should be well-versed in the AMA Manual of Style. Syneos Health is committed to developing its employees through career progression, supportive management, training programs, peer recognition, and a total rewards program. The company fosters a Total Self culture that values authenticity and diversity of thoughts, backgrounds, and perspectives to create an inclusive work environment where everyone feels they belong. By joining Syneos Health, employees have the opportunity to work in a collaborative and innovative setting dedicated to accelerating the delivery of therapies and changing lives. For more information about Syneos Health and its impact in the healthcare industry, please visit http://www.syneoshealth.com. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive, and the company reserves the right to assign additional responsibilities at its discretion. Equivalent experience, skills, and education will also be considered in evaluating candidates for the position. The language used in this description complies with all obligations imposed by relevant legislation, including the Americans with Disabilities Act.,

Posted 2 days ago

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