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Medical Writing Project Manager (Rockland or Billerica, MA)

At EMD Serono, The Medical Writing Project Manager will facilitate the global, cross-functional Integrated Clinical Review Committee (ICSC), Therapeutic Area Review Boards (TARBs) and First in Human Review governance boards.  These committees are responsible for overseeing protocol design and operational planning of clinical studies. 

 

Your role:

  • Arranging all logistical and technical needs for meetings
  • Producing and distributing minutes, tracking actions, and reporting
  • Training members and study teams on the governance process and acting as a first point of contact for process-related questions
  • Developing and maintaining systems for calculating and reporting KPIs as well as templates and committee charters
  • Managing governance SharePoint sites, ensuring appropriate confidential access
  • Ensuring inspection readiness for all governance decisions.

 

 

Who you are:

Minimum Qualifications:

  • Bachelor’s degree

     

Preferred Qualifications:

  • Bachelor’s in Biology, Chemistry, or other Science Discipline
  • 3+ year’s experience in pharmaceutical/biotechnology industry
  • Proven training ability
  • Knowledge of Clinical Study Protocols
  • Knowledge of computer applications particularly Adobe Acrobat, Microsoft Word, PowerPoint, Outlook, SharePoint and knowledge of interaction of programs
  • Initiative and ability to work with minimal supervision
  • Ability to work well with others at all levels in the organization in high pressure situations
  • Strong organizational and communication skills

 

This role can sit at our Rockland or Billerica, MA site

Job Requisition ID:  189625
Location:  Rockland
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

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