Senior Principal Medical Writer

Posté 08 août 2022

Billerica, Massachusetts - United States

Demander un identifiant 251439

 

A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.


United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.


Your role: As Senior Principal Medical Writer you will lead the Medical Writing effort for global, priority programs. The role leads independantly MW deliverables for complex global programs, such as Protocols, Clinical Study Reports, IBs, Briefing Books, Clinical Summaries, Pediatric Plans, responses to authorities, etc. and ensure alignment of messaging. You act as the Lead Writer/oversight for clinical sections of eCTDs for global market approval and represent department on clinical teams, lead document-related meetings, review statistical analysis plans.

The role contributes to overall project management and cross-functional working groups to facilitate efficient development and finalization of regulatory documents for submission and provides document strategy and resource needs for an indication/program. The Senior Principal Medical writer oversees work of vendors supporting program deliverables and attends governance meetings for protocol discussions. The role proactively contributes to development and implementation of MW best practices and improvements. We are calculating travel up to 10% for this role. 

 

Who you are:

 

Minimum Qualificaitons:

  • Minimum BS in a scientifc or writing discipline; MS or PhD preferred
  • Minimum 5+ years related experience
  • Strong Clinical Trial Development knowledge

 

Preferred Qualifications:

  • Thorough understanding of drug development and strategy for regulatory submissions
  • Strong communication and organizational skills
  • Shows innovation and ability to implement change
  • Ability to coordinate work of multiple writers and vendor resources
  • Expert in Word/Adobe/Electronic document management systems

 


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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