Principal Medical Writer

This is a position for an experienced medical writer who is able to take full responsibility for the preparation of clinical documents and regulatory dossiers/ including clinical protocols/ study reports, Clinical Investigator Brochures, INDs/IMPDs, and CTDs according to company and agency guidelines. He/she creates clinical documentation according to company guidelines and international government regulations and presents clinical data objectively in a clear/ concise format. He/she provides scientific knowledge, analytical skills, and insight to the Clinical Teams and contributes to CTD Task Force meetings and cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.

The successful candidate will have a background demonstrating fully acquired competences in writing/ editing/ and reviewing all types of clinical documents including registration dossiers.

In addition, the candidate ideally has the following qualities:

• Good understanding of drug development/ clinical research/ study design, biostatistics, the regulatory environment/ and medical terminology.
• Detail-oriented with excellent interpersonal and communication skills.
• Ability to work both autonomously and collaboratively with a team in a multicultural, multilingual, and geographically dispersed environment.
• Possesses a sense of urgency and is deadline oriented.
• Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
• Native English speaker or with proven excellent spoken and written English.
• Possesses a solid work ethic, professionalism organizational ability and follow-up skills.
• Experience in immunology or vaccines is a plus

Education and /or Experienced Required

• Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.
• Work experience of more than 3 years as a medical writer or equivalent, or presenting relevant specialist qualifications.