Search TSR Jobs

About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Medical Writer

Job Description

  • Location: Princeton, NJ
  • Type: Contract
  • Job #66672

Our client, a leading pharmaceutical company is hiring a Medical Writer on a contract basis.

Work Location

Princeton, NJ

Summary

Expected Areas of Competence:

• Ability to develop a range of written materials such as detailed instructions for high level principles-based documents

• Demonstrated ability to write complex processes in a logical order using simplified language, creation of visual process flow diagrams, and information mapping techniques

• Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape

• Ability to effectively manage projects, escalate issues as necessary and meet key milestones

• Ability to lead and facilitate writing team meetings, that contribute to attaining team goals and resolving complex issues

• Ability to evaluate utility of documents and assemble content to ensure clarity for users (including those who are not native English speakers)

• Collaboratively work with Regulatory and Clinical colleagues to ensure any process changes resulting from the issuance of new or revised GCP/ICH Guidelines, regulations, and other guidelines applicable to clinical research are documented appropriately, in an appropriate format

• Work with autonomy and is able to able to negotiate and influence others without direct authority

 

Qualifications:

• Bachelors degree with a minimum of 5-10 years experience in global drug development

• Demonstrated knowledge of Good Clinical Practice (GCP) ICH

Guidelines and applicable FDA regulations

• Project Management:

o Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations

o Demonstrated ability to maintain a high level of productivity, accountability and energy

o Demonstrated success in managing project team effectiveness, through facilitation and presentation skills to a globally diverse audience

• Document Development and Review:

o High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper

o Provides close attention to detail and excellent follow up

o Ability to take very detailed information and distill it down to focus on key messages

• Flexible thinker with a growth mindset

o Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans

o Affinity towards fully utilizing technology

 

 

Include a message to the recruiters.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!