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Senior Principal Medical Writer

Your role:

  • Lead the Medical Writing effort for global, priority programs
  • Independantly lead MW deliverables for complex global programs, such as Protocols, Clinical Study Reports, IBs, Briefing Books, Clinical Summaries, Pediatric Plans, responses to authorities, etc.
  • Ensure alignment of messaging
  • Act as the Lead Writer/oversight for clinical sections of eCTDs for global market approval
  • Represent department on clinical teams, lead document-related meetings, review statistical analysis plans
  • Contribute to overall project management and cross-functional working groups to facilitate efficient development and finalization of regulatory documents for submission
  • Provide document strategy and resource needs for an indication/program
  • Oversee work of vendors supporting program deliverables
  • Mentor Writers
  • Attend governance meetings for protocol discussions
  • Proactively contribute to development and implementation of MW best practices and improvements
  • Travel up to 10%
  • Ideally based in Rockland or Billerica, but remote is also a possibility

 

Who you are:

Required:

  • Minimun BS in a scientifc or writing discipline; MS or PhD preferred
  • Minimun 5-8 years related experience
  • Strong communication and organizational skills
  • Strong Clinical Trial Development knowledge
  • Thorough understanding of drug development and strategy for regulatory submissions
  • Shows innovation and ability to implement change
  • Ability to coordinate work of multiple writers and vendor resources
  • Expert in Word/Adobe/Electronic document managment systems
Job Requisition ID:  210433
Location:  Rockland
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

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.

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