We are in the process of establishing a web-based organization that will act as a support and educational resource for medical/scientific writers, as well for other professionals within the clinical research industry. Currently, we are seeking to identify and hire freelance medical writers with extensive experience in regulatory writing to
develop educational materials. This is a telecommuting position, which enables you to work anywhere.

 

 

Ideal individuals need to have the following qualifications:

At least 5+ years of experience in regulatory writing

Outstanding oral/written communication skills

Experience in writing sections of the Common Technical Document (CTD and eCTD)

Experience in writing safety reports (i.e. PSUR, DSUR) is a plus

Well informed in the ICH, GCP and other regulatory guidelines.

Ability to synthesize complex information into a level that is easy to comprehend by novice and or neophyte writers

Ability to create content from inception to completion

Good knowledge in designing printed instructional materials.

Computer skills: MS Office, Adobe Acrobat, Reference Manager

Knowledge in the drug development process is a plus

A minimum of a Bachelor´s degree in applied science/life science or communications (journalism, English) will be considered. An advanced degree is a plus.

Contact:

 

Qualified individuals are encouraged to submit  their curriculum vitae with a cover letter, a writing sample, and requirements for compensation (hourly rate) to Jgg2014@gmail.com. We regret, but only candidates meeting the specified qualifications and including their compensation requirement in their submission will be contacted for further discussions.

8-month on-site contract positioni

 

Write, edit, and coordinate cross-functional review of documents to support submissions to regulatory agencies, including Investigator's Brochures, Clinical Study Reports, IND Annual Reports, Briefing Documents, CMC updates for late-stage development product candidates.

Bachelors degree REQUIRED, advanced degree preferred

5+ years in the pharmaceutical/biotechnology industry.

3+years clinical/regulatory medical writing experience REQUIRED

Knowledge of drug development under US and EU Regulations and ICH guidelines.

Proven skills in writing and editing documents for regulatory submissions and publications.

Project management within Medical Writing a HUGE PLUS to be able to help push things through channels.

Microsoft Office proficiency

Able to work in a fast-paced, team-oriented, small-company environment.

Contact:

 

Qualified individuals are encouraged to submit  their curriculum vitae with a cover letter, a writing sample, and requirements for compensation (hourly rate) to Jgg2014@gmail.com. We regret, but only candidates meeting the specified qualifications and include compensation requirement in their submission will be contacted for further discussion.