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Medical Writer Ii

3 months ago

Gurgaon, Haryana, India Syneos Health Clinical Full time

Description

Medical Writer II (Clinical Trial Transparency & Redaction):

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.


Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • 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.
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Should have good knowledge of redactions/anonymization of clinical documents
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Should have experience in preparing disclosure documents for and for various other clinical registries will be added advantage
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Good understanding of Clinical Trial Disclosure.

Job responsibilities

1. Authoring and Quality Assurance of Project Activities:

  • Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures
  • Marking /QC/Review and/or editing of pertinent documents such as:
  • Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH)
  • Protocol and results summaries to support clinical trial disclosure commitments
  • Systematically perform quality control checks of documents prepared by colleagues against prespecified checklist 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 will be preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for 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.
  • 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
  • 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 proactivity
  • Effective team working
  • Ability to build rapport/ relationships with projectspecific client colleague

Get to know Syneos Health


Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.


No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

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 incumbe