Senior Medical Writer

Facility:  Clinical Development and Medical
Location: 

Lexington, MA, US

About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference? 

 

The Position

The Senior Medical Writer will be a key member of the project team and will work closely with Clinical Operations and Regulatory Affairs to manage all aspects of clinical/regulatory document preparation, including protocols, CSRs, Investigator Brochures, and other regulatory submission documents, according to company guidelines and international governmental regulations.

 

Relationships

This role will report to the Head of Medical Writing. This role will work cross-functionally with other departments.

 

Essential Functions

  • Collaborate with medical directors, clinical scientists, biostatisticians, and other clinical team members (“study team”) to develop and draft, edit, and finalize Phase 1-3 clinical protocols and protocol amendments
  • In collaboration with the study team, draft, edit, and finalize CSRs for Phase 1-3 clinical studies
  • In partnership with biostatisticians, review draft SAPs and TLF shells to ensure they can deliver the information required by the target audience
  • Collaborate with study team members to ensure study results and statistical interpretations are accurately and clearly presented in relevant documents
  • Collaborate with clinical, nonclinical, and CMC teams to draft, edit, and finalize initial IBs, as well as review and update IBs annually, or as needed
  • Plan and lead document review meetings to achieve consensus on document strategy, content, and format
  • Ensure that documents meet their intended purpose and are prepared in accordance with internal standards and SOPs and external regulatory guidelines
  • Coordinate QC review of clinical and regulatory documents
  • Represent Medical Writing in regularly scheduled clinical project team meetings

 

Physical Requirements

0-10% overnight travel required. Ability to lift 0-10 lbs.

 

Qualifications

  • Minimum of bachelor’s degree, preferably in a health-related or scientific discipline
  • A minimum of 5 years medical writing experience in a pharmaceutical, biotechnology, or CRO environment is required
  • Experience writing Phase 1-3 clinical protocols and CSRs required
  • Experience writing Investigator Brochures, eCTD modules, and regulatory briefing documents desired
  • Thorough knowledge of clinical research concepts and practices, and FDA regulations and ICH Guidelines regarding drug development and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Exceptional written and verbal communication skills
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • Expert-level MS Word skills. Experience with StartingPoint and Sharepoint desirable         
  • Ability to manage complex projects with minimal supervision
  • Ability to work well under pressure and adapt to change as needed

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.