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Sr Medical Writer (Clinical Trial Disclosure)

Senior Medical Writer

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on t aking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

JOB SUMMARY

CTD plays a critically important role in executing projects for Syneos global clients. He/she works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical and technical information.

JOB RESPONSIBILITIES\

1. Authoring and Quality Assurance of Project Activities

  • Undertakes project specific activities at high quality and in defined timelines according to standard processes and operating procedures
  • Authoring and/or editing of pertinent documents such as:
  • Clinical study documents or documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc.
  • External scientific communications i.e. manuscripts, abstracts, response documents, etc.
  • Protocol and results summaries to support clinical trial disclosure commitments
  • Systematically perform quality control checks of documents prepared by colleagues against pre-specified check-list generated in the project or SOP
  • Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs


Ensure to abide with Client process

  • Medical writer who will be preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various clinical registries


2. Additional Activities

Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s)

Qualifications:
What we're looking for

  • Educational qualifications: A minimum of a scientific graduate degree in life sciences and require min 6 years of experience in Medical Writing
  • Must have experience in clinical trial protocol and results disclosure(Mandatory).
  • Good knowledge of regulatory requirements or guidance pertinent to the service line.
  • Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills
  • Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
  • Person should understand & comprehend protocol and clinical study report from disclosure perspective.
  • Good understanding of clinical trial disclosure fundamental
  • Core competencies for this role include ability to demonstrate:
    • Analytical capabilities with scientific and clinical data.
    • Professional working environment
    • Ownership of the work allocated
    • Commitment to highest quality outputs, including high attention to detail
    • Enthusiasm and pro-activity
    • Effective team working
  • Ability to build rapport/ relationships with project-specific client colleague


Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Sr Medical Writer (Clinical Trial Disclosure)

160014
Full Time

Published on 05/13/2022

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