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FSP - Senior Medical Writer

USA - Any Region - Home Based Date posted 12/19/2021 Job ID 78598BR

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Detail-Oriented
  • Deadline-Oriented
  • Communicator
  • Organized
  • Versatile
  • Tech-Savvy
  • "I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,
    knowledgeable, and it is easy to communicate with other staff."

    Christine, Medical Writer II
  • "Parexel makes it easy to communicate and interact with each other, which allows
    me access to expertise and knowledge beyond my own."

    Kristy, Associate Manager

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Work-life Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Career Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Home based

    Love where you work, and work where you love.

  • Variety

    Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

Responsibilities

About Parexel FSP:

We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

The Senior Medical Writer (Sr MW) writes/edits clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other documents for submission to the Food and Drug Administration (FDA) and other regulatory authorities; and develops abstracts, manuscripts, and presentation materials summarizing clinical data.
Organizational Relationships:
  • Reports to ExecuPharm assigned Line Manager with day-to-day direction from the Client.
  • Liaises with cross functional lines/vendors as appropriate.
Primary Duties:
  • Write/edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
  • Develop manuscripts and presentation materials
  • Develop and manage timelines for document development
  • Coordinate multi-document projects
  • Represent medical writing on study teams and cross-functional strategic teams
  • Work on problems of diverse scope where decisions are based upon a mixture of analysis, wisdom, experience, judgment, and rigorous logic and methods
  • Acts independently to determine methods and procedures on new assignments action
  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
  • Adhere to EP and Client SOPs and processes

Qualifications

Skills and Education:
​​​​​
  • BA/BS in life sciences and a minimum of 5 years’ experience or MS/PhD and a minimum of 2 years’ experience
  • Solid understanding of FDA/ICH guidelines and GCPs
  • Experience preparing clinical regulatory documents and scientific publications
  • Experience with Module 2 required
  • Expert abilities in Microsoft Word, Excel and PowerPoint
  • Experience with Adobe Acrobat
  • Prior NDA/BLA/MAA submission experience
  • Strong written and verbal communication skills
  • Ability to coordinate and prioritize multiple projects in a fast-paced environment
  • Ability to anticipate and address issues with potential to impact timelines

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

#INFSP

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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