Sr. Medical Writer

  • Location
    Princeton, New Jersey
  • Job type
    Direct Hire
  • Category
    Medical & Science - Regulatory

A Sr. Medical Writer near Princeton, New Jersey is anticipated courtesy of Adecco Medical and Science. Within this position you will focus on the preparation, assembly, writing, and review of the documentation needed to support Phase I-IV clinical development programs. Candidates must have a strong regulatory background.


Sr. Medical Writer responsibilities include:

As needed, preparation of or assistance with clinical study protocols and protocol amendments, clinical study reports and appendices, or other regulatory documents.
Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures, internal Style Guide) will be expected to perform the above functions. Additionally, you must be able to work independently and efficiently with cross-functional team members.
Development or updating of Investigator’s Brochures, Periodic and Developmental Safety Update Reports, and related regulatory documents.


QUALIFICATIONS:

Bachelor’s degree plus 5 to 7 years industry experience
Master’s degree plus 2 to 5 years industry experience
Ph.D., Pharm.D., or equivalent plus 1 to 2 years industry experience
Previous experience in the writing of clinical/regulatory documents, such as protocols, investigator brochures, safety updates, and clinical study reports
Proven capacity in translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians
Training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry, and/or biotechnology
Ability to prepare deliverables in accordance with pre-established timelines, systematically performing activities in a timely and accurate manner
Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat
Understanding of medical terminology and AMA style
High attention to detail
Legally authorized to work in the United States, and not requiring, now or in the future, sponsorship for employment visa status


If you are interested in this Sr. Medical Writer job near Princeton, New Jersey then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

  • Apply with Adecco

Reference number US_EN_2_106405_329624