Accessibility Links

Manager, Medical Writer

  • Job type: Permanent
  • Location: Boston
  • Salary: $100000 - $120000 per annum
  • Job reference: 332659
  • Sector: Medical Affairs, Pharmacology, EPM Scientific
  • Date posted: 02/02/2018
One of the leading companies in Pharmaceuticals is in search for a talented Manager, Medical Writing. This is the perfect fit for a skillful regulatory writer who is looking to join a rapidly growing team and a company that prides itself on high-quality work and employee satisfaction. The Medical Writing Manager will work closely with Research, Clinical Operations and Regulatory Affairs to manage all document submissions for both clinical and regulatory documents.

Job Overview 


  • Lead the preparation of all clinical and regulatory deliverables including but not limited to CSRs, Protocols, IBs, DSURs/PSURs, in collaboration with members of client authoring teams
  • Act as head project manager of assigned client deliverables and documents
  • Review all regulatory/clinical documents composed by outside sources
  • Ensure that all documents are aligned with agreed timelines, manage project budgets, adhere to: SOPs, GCP and ICH, and meet the requirements of assigned client(s)
  • Responsible for providing document-specific advice to clients
  • Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format
 


Skills Required 


  • BA/BS within a scientific discipline, advanced degree preferred
  • At least 3-5 years of clinical and regulatory writing experience within the pharmaceutical/biotechnology or CRO industry
  • Has acted as the lead writer on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications
  • Exceptional written and verbal communication skills
  • Competency in the using document management systems
  • Knowledgeable in ICH, EMEA and FDA guidelines.
Similar jobs
Sr. Validation Engineer
  • Job type: Permanent
  • Location: Chicago, Illinois
  • Salary: Negotiable
  • Description Position: Sr. Validation Engineer, QA Location: Chicago, IL Responsibilities: Provid engineering assistance regarding validation & verification requirements of medical device processes
Senior Manager, Regulatory Affairs (Contract)
  • Job type: Contract
  • Location: San Francisco, California
  • Salary: Competitive
  • Description Senior Manager, Regulatory Affairs (Contract) An established, global pharmaceutical company in the San Francisco/Bay area is looking to bring on a Regulatory Affairs Senior Manager for a long-term
Senior Medical Writer - Med Comms (Remote)
  • Job type: Permanent
  • Location: New York
  • Salary: US$85000 - US$105000 per year
  • Description Job Summary: An excellent agency within a growing network of agencies is looking for an outgoing Senior Medical Writer to join the team. This position has been opened as a growth position and it is a
Associate Medical Director
  • Job type: Permanent
  • Location: New York
  • Salary: US$100000 - US$120000 per year
  • Description Job Summary: Established and growing Medical Communications agency is seeking to add an Associate Medical Director to one of their scientific teams. This agency has grown over 15% year over year
Senior Medical Writer
  • Job type: Permanent
  • Location: Yardley, Pennsylvania
  • Salary: US$80000 - US$100000 per year
  • Description Job Summary: A rapidly growing Medical Communications agency is looking for a Senior Medical Writer to join the publications scientific team. The organization strives to partner with elite