Medical Writing Operations Associate

Inozyme

Boston, MA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 06/08/2021
  • Website: inozyme.com
  • Company Address: 700 TECHNOLOGY SQUARE FLOOR 2, Cambridge, MA, FLOOR 2

About Inozyme

We are a biopharmaceutical company specializing in the development of novel therapeutics to treat rare metabolic diseases.

Job Description

Company Summary:

Inozyme Pharma is a biotechnology company committed to developing novel medicines for the treatment of rare metabolic diseases characterized by mineral imbalances. We are singularly focused on developing new therapies for patients with devastating rare diseases.  The company was founded in 2016 with technology licensed from Yale University and is well financed by a premier syndicate of venture investors.  Inozyme Pharma is led by an experienced management team with a proven track record in rare disease drug development, regulatory approvals, manufacturing and operations.

Our employees are central to our ability to achieve our goals of helping patients. We’re looking for people to join our team who are collaborative, compassionate, resilient, and passionate about what we do.

 

Description:

Inozyme is seeking a Medical Writing (MW) Operations Associate to join our growing team. This person will play an integral role in providing scientifically accurate, high-quality documents throughout all stages of drug development. The MW Operations Associate will ensure quality review of clinical and regulatory documents and MW process documentation.

Position Reports to: Director, Regulatory Affairs & Medical Writing

Essential Duties and Responsibilities:

  • Performs advanced editing, formatting, fact-checking, and content quality control reviews of regulatory and clinical documents (e.g., clinical study protocols and reports, Investigator’s Brochures, and regulatory submission modules)
  • Collaborate with other functions to collect, file, and track appendices for clinical study reports
  • Provides troubleshooting and training to all levels on key MW processes and systems
  • May develop and update SOPs, work instructions, templates, and checklists
  • May supervise or lead MW initiatives related to document development, quality, and improvement (such as managing systems or developing and implementing new tools)
  • Communicates ideas for new processes and/or business operations for process improvement

Education/Qualifications:

  • B.S. (or equivalent) and at least 2 years of relevant work experience (biotech/pharma preferred)

Requirements:

  • Outstanding attention to detail related to consistency, grammar, and accuracy according to source documentation
  • Proficient in use of Microsoft Office (including Word, Powerpoint, and Excel) and Adobe Acrobat
  • Previous experience with EDMS, electronic Common Technical Document (eCTD) viewer, and EndNote a plus
  • Knowledge of ICH guidelines relevant to Medical Writing
  • Excellent communication skills; ability to communicate effectively, both in writing and verbally
  • Ability to complete work in a resourceful, self-sufficient manner, with some guidance and mentoring on new or complex issues
  • Excellent organizational skills; ability to prioritize tasks and to work on multiple projects at the same time with overlapping timelines
  • Demonstrated ability to work both independently and in collaboration with others
  • Exhibits sound judgement and decision-making in a dynamic, regulated environment
POSITION:Full-Time, Exempt, Boston, MA

EEOC Statement:

To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job’s alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.

Related Jobs

Director of Clinical Operations

Inozyme - Boston, MA, US

Patent Agent

Inozyme - Boston, MA, US

Staff Accountant

Inozyme - Boston, MA, US

Paralegal/Contracts Administrator

Inozyme - Boston, MA, US

Associate Director, Clinical Project Management – Sr. Clinical Project Manager

Inozyme - Boston, MA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.