Medical Writer II

Mansfield, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Medical Writer based in Mansfield, Massachusetts, with the possibility of working from a remote location. The Medical Writer is responsible for the preparation of documents that support the presentation and publication needs of assigned therapeutic areas and products. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports, clinical study reports, summaries) documents and responses to Notified Bodies
  • Post Market Surveillance activities (monthly literature review of our product) 
  • Scientific Writing e.g. abstracts, manuscripts, presentations 
  • Critically writes and edits scientifically complex documents for substantial intellectual content 
  • Reviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goals 
  • Expert knowledge of clinical research, device or drug development processes, regulatory requirements, and good clinical practices 

EXPERIENCE

  • A minimum of 4 years of relevant pharmaceutical and medical device industry experience 
  • Demonstrated scientific writing ability 
  • Must be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and 
  • PowerPoint), skill in Microsoft Excel, Photoshop, Illustrator, EndNote Reference Software, and 
  • other scientific graphics software 
  • Good understanding of statistical methods 
  • Requires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical data 
  • Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences 

EDUCATION  

  • Bachelor of Science, B.Pharm, Master’s Degree
  • PhD or PharmD (with 1 to 2 years of related pharmaceutical or medical device industry experience 
  • (e.g., medical writing, clinical research) 
  • Communication and Presentation Skills 
  • Expert understanding of scientific or clinical research and the scientific method 

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176