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Senior Medical Writer

USA - Any Region - Home Based Date posted 06/12/2021 Job ID 66851BR

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

At Parexel you’ll team up with some of the best minds in the industry to get new treatments to the patients who need them most. Right now we are recruiting for Home Based Senior Medical Writers and Principal Medical Writers.

Parexel is one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are currently looking for:

Home Based Clinical Regulatory Medical Writers in the US and Canada (Full Time & Temporary Roles Available)

As a Parexel Medical Writer, you will be exposed to different project teams, therapies and devices, as well as a diverse portfolio of clients. The ability to understand our clients’ needs and achieve quality results is critical for us to continue to be one of the best clinical research organizations (CROs) in the world. To accomplish this, we believe that you must have the ability to work independently as well as collaboratively every day.

As a Senior Medical Writer with Parexel you will research, create, and edit all documents associated with clinical research. Responsibilities include: lead author and primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.

Our writers are an integral part of clinical teams that support our clients worldwide and they assist those teams in writing and coordinating successful documentation across a wide range of therapeutic areas.

You will:
  • Use your clinical knowledge to write and edit clinical study documents
  • Use your project management skills to lead teams to quality and timely deliverables
  • Partner with sponsors as their primary client contact for medical writing projects
  • Mentor and train junior medical writing staff

Qualifications

Skills:
  • Excellent interpersonal, verbal, and written communication skills.
  • Consistently produces documents of high quality.
  • The ability to stay focused under tight timelines.
  • Attention to detail and proactivity.
  • Understands all necessary steps in a project, plan ahead, and identify critical paths.
  • A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
  • Efficiently manages time spent on tasks and proactively identifies deficiency. Manages multiple and varied tasks with enthusiasm and prioritizes workload with attention to detail, e.g., organizational skills.
  • Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
  • Negotiates on behalf of medical writing to ensure resources, timelines and expectations are aligned.
  • Understands and satisfies client needs.
  • Gains trust and establishes a connection with the client beyond one's project.
Knowledge and Experience:
  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
  • Accountable to provide document-specific advice to clients.
  • Scientific background essential.
  • Extensive clinical/scientific writing experience is required and consists of multiple clinical documents: study reports, study protocols, CTD documents and/or similar.
  • Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge and ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
Education:
  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

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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