Senior Medical Writer, Oncology

Date: Jul 10, 2019

Location: Boston, MA, US

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Requisition ID: CLI008378

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


The Senior Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals.  In this role the Senior Medical Writer: 
  • Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.
  • Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally).  
  • Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. 
  • Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. 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.  
  • May participate in orientation and coaching of junior team members or contractor writers.
  • May participate in initiatives to improve medical writing processes and standards.

Qualifications

Education Minimum Requirement:  Bachelor's Degree or higher in the Life Sciences

Required Experience and Skills:   
  • Minimum of 3 years of experience as a medical writer preparing regulatory documents in the pharmaceutical and/or biotech industry, or closely related experience.  Ability to prepare clinical regulatory documents according to company guidelines and international governmental regulations. Ability to present clinical data objectively in a clear, concise format.
  • Participate actively in cross-functional project teams. 
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems and software, and familiarity with SharePoint.
  • Excellent oral (including presentation) and written communication, and project management skills. 

Preferred Experience and Skills:
  • Experience in oncology regulatory writing
  • Advanced degree in Life Science
  • Familiarity with concepts of structured content management

*Ideal candidate must reside in Boston area/domestic relocation available


If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Clinical Research - Clin Ops
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable): N/A
Hazardous Materials: no
Company Trade Name: Merck


Nearest Major Market: Boston

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