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Principal Medical Writer, Medical Writing Services

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Expert & Leadership (>10 years)
Work from: 

Offer summary

Qualifications:

10+ years experience in regulatory medical writing, Experience in authoring clinical documents, Knowledge of multiple therapeutic areas, Bachelor's/advanced degree in life sciences/healthcare, Background in pharmaceutical/CRO industry.

Key responsabilities:

  • Research, create, and edit clinical documents
  • Act as project lead writer/submission coordinator
  • Manage contributions from multiple writers
  • Facilitate process improvement and mentoring
  • Support sales process with client proposals
Parexel logo
Parexel Pharmaceuticals XLarge http://www.parexel.com/
10001 Employees
See more Parexel offers

Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Principal Medical Writer, will research, create, and edit all documents associated with clinical research. The Principal Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Principal Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input.

Minimum Qualification Requirements:

  • Candidate must have 10+ Years experience in regulatory medical writing. Experience in authoring protocols, clinical study reports, investigator’s brochures, informed consent forms, summary documents, etc.
  • Experience in multiple therapeutic areas, including but not limited to vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology oncology, etc.
  • Strong communication and interpersonal skills.
  • Bachelors/advanced degree or equivalent education/degree in life sciences/healthcare.
  • Experience from the pharmaceutical /CRO industry.
  • Ability to work independently and lead projects.
  • Strong analytical skills.
  • Commitment to highest quality outputs, including high attention to detail.
  • Ability to manage variable workload.

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Quality Control
  • Mentorship
  • Social Skills
  • Analytical Skills
  • Verbal Communication Skills
  • Detail Oriented

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