Principal Medical Writer

Medical writerMedical writerFull TimeRemoteLeadTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Spain

Posted

15 days ago

Salary

0

Seniority

Lead

Bachelor Degree5 yrs expEnglish

Job Description

Principal Medical Writer

Syneos Health

• The Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. • Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. • Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. • Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. • Mentors less experienced writers.

Job Requirements

  • Bachelor's degree required.
  • Advanced degree in a relevant scientific/clinical/regulatory field preferred.
  • At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
  • Proficiency in organizing and communicating clinical information required with minimal oversight.
  • Strong organizational, time management, and project management skills are required.
  • Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
  • Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired.
  • Proficient in MS Word.
  • Experience with an electronic document management system and templates is required.

Benefits

  • 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.
  • committed to building an inclusive culture – where you can authentically be yourself.

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