Medical Writer Job at Precision Life Sciences, Boston, MA

UDVpRUhpNFk3NzZGeExDcFlGazhld1dIVFE9PQ==
  • Precision Life Sciences
  • Boston, MA

Job Description

Job Title: Medical Writer

PRINCIPLE DUTIES:

  • Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents 
  • As needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents 
  • Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients 
  • Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents 
  • Lead document review meetings and discussions 
  • Provide direction and solutions to cross-functional teams on expectations for document content 
  • Perform QC of clinical and nonclinical documents 
  • Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines 
  • Participate in project team meetings 

QUALIFICATIONS/EXPERIENCE:

  • Minimum of Bachelor’s degree in science (Masters or Ph.D. preferred) 
  • Experience in IND and/or NDA submissions and writing CSRs, IBs, clinical study protocols, and other documents for regulatory submissions 
  • A minimum of 5 years in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred. 
  • Strong scientific background in rheumatology, endocrinology, metabolic disease, or related field 


KEY COMPETENCIES:

  • Excellent verbal and written communication skills in English 
  • Knowledge of FDA, EMA, and ICH guidelines. 
  • Deep understanding of the drug development process and prior experience in the biopharmaceutical industry particularly in preparing the NDA. 
  • Excellent time- and project management skills, attention to detail, and ability to balance multiple projects simultaneously 
  • Strong critical and logical thinking with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution 
  • Ability to work collaboratively in a dynamic environment 
  • Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates 

Job Tags

Similar Jobs

System One

Azure Engineer Job at System One

 ...Project Management, Application Development, Cybersecurity, Data & Advanced Analytics, and Agile Transformation Services. Azure Engineer 100% Remote Summary: This role is responsible for providing Cloud technical leadership to internal business lines and... 

WellSpring School of Allied Health

Medical Assisting Instructor - Adjunct Job at WellSpring School of Allied Health

 ...-oriented professions. Job Description We are looking for a driven, energetic, highly skilled person to join our Medical Assisting instructor team. The program is delivered in a classroom setting and prepares students for a career in the healthcare field. This is... 

MH CIVIL CONSTRUCTORS, INC

Equipment Operator (Operador de Equipo) Job at MH CIVIL CONSTRUCTORS, INC

 ...Challenge: The excavator operator will operate machinery for construction, demolition, and excavation projects including excavating,...  ...machinery to dig holes and trenches used in structural concrete and pipeline. # Transports tools and other construction equipment to and... 

C&S Wholesale Grocers

Facilities Maintenance Supervisor Job at C&S Wholesale Grocers

 ...Position Overview The Facilities Maintenance Supervisor provides functional leadership to the Facilities Maintenance staff, including shared responsibility for hiring, training, coaching and progressive discipline. The Supervisor is responsible for overseeing the safe... 

Sago

Call Center Supervisor Job at Sago

 ...The Cell Center Supervisor, internally known as Recruiting Supervisor, helps train and motivates recruiting staff as they answer questions...  ...will ensure that every staff member is well prepared for their calls. They will continue to support staff after training by...