Medical Writer II (Clinical Trial Transparency) Syneos Health

2.0 - 6.0 years

0 Lacs

haryana

On-site

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. - Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. - Collaborate with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deli...

Posted 2 weeks ago

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Trial Vendor Senior Manager Novartis India

3.0 - 5.0 years

0 Lacs

hyderabad, telangana, india

On-site

Summary When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are currently looking for a Trial Vendor Senior Manager to join our team in London. This is a hybrid position with 12 days a month from our White City offices. The main purpose of this position is to be accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. To collaborate with the VSM for the VSM's category specific responsibilities and be responsible for all activities for which no VSM is assigned...

Posted 3 weeks ago

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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, y...

Posted 3 months ago

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Manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Ocugen

8 - 10 years

12 - 15 Lacs

Hyderabad

Work from Office

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality sta...

Posted 5 months ago

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