Job Type

Contractor

Posted

1 day ago

Location

Kenilworth, NJ

Description

MEDICAL WRITER
KENILWORTH, NJ
 
Position is ​fully remote, about 8 months - Possible 3 month extension

Project Description:
  • Acts a capable scientific contributor and subject matter expert in preparation of selected scientific response documents (SRD).
  • Applies developing knowledge of medical writing and therapeutic area/investigational product to support projects around dissemination and communication of projects surrounding medical congresses.
  • Participates as part of the medical writing team in cross-functional teams.
  • Demonstrates competence in writing, editing and reviewing of SRDs in line with expectations.
  • Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to congress portal preparation.
  • Manages medical writing projects including the design, planning, and preparation of documentation in support of company goals.
  • Works collaboratively with colleagues across functions to achieve results.
  • Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members.
  • Creating materials for field medical scientific exchange

Required Skills:
  • Degree in the Life Sciences - Bachelor's degree with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience.
  • Experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
  • Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • Participate actively in medical writing and cross-functional project teams.
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
  • Excellent oral (including presentation) and written communication, and project management skills.
  • Awareness of pharmaceutical industry needs beyond clinical development. 3-8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
  • Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • Participate actively in medical writing and cross-functional project teams.
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
  • Excellent oral (including presentation) and written communication, and project management skills.
  • Awareness of pharmaceutical industry needs beyond clinical development.
  • Ability to work weekends



This 8+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jennifer:

jennifer@alphaconsulting.com



ALPHA'S REQUIREMENT #21-01311
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#ZR
#LI-JH1

About the Company

Alpha Consulting Corp.

Our goal, in addition to communicating the benefits of becoming associated with Alpha Consulting, is to provide news, opinions, and resources to assist Clients and Consultants. As with our careers, the content will continuously change and evolve over time.

Alpha Consulting Corporation is an IT (Information Technology) staffing business specialty with the ability to understand your specific project requirements and promptly supply appropriately matched consultants to fill both short and long-term client needs.

Company Size

100 to 499 employees

Industry

Biotechnology/Pharmaceuticals

Founded

1994

Website

http://www.alphaconsulting.com/