Principal Medical Writer- MedPubs Focus

Veristat•Massachusetts, MA

1d•$132,000 - $151,000•Remote

About The Position

The Principal Medical Writer independently plans and prepares a range of regulatory documents and/or medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines (International Council for Harmonisation (ICH) and other regulatory guidelines, or International Committee of Medical Journal Editors (ICMJE) and Good Publications Practice (GPP) guidelines, as appropriate) and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams as appropriate.

Requirements

Bachelor’s degree required
Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting.
Experience as a lead writer on a minimum of 20 manuscripts, 20 abstracts, 20 posters or oral presentations across all phases of drug development and therapeutic areas.
Advanced knowledge of ICH and related regulatory guidelines and/or ICMJE and GPP guidelines
Proficient in MS Office Suite (advanced MS Word, PowerPoint and Excel); Adobe Acrobat for developing and editing poster slides, pdf poster layouts and slide sets
Knowledge publication guidelines and industry standards, adherence to client publication policies and procedures, confidentiality, secure file transfer, copyright and privacy protection.
Excellent oral and written communication skills to work across an organization, facilitate discussions with clients and internal and external authors
Strong analytical skills to anticipate client needs within client engagements, identify where improvements can be made and offer suggestions for making work more efficient
Maintain industry knowledge, identify and adopt work practices that are the most effective to ensure consistency in performance for self and the team

Nice To Haves

PhD, MD or PharmD preferred
science-related field preferred
ISMPP CMPP certification preferred

Responsibilities

Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines (ICH and other regulatory guidelines, or ICMJE and GPP guidelines, as appropriate) and individual company document standards.
Collaborating with cross-functional internal and external document production teams as appropriate.