Medical Writer Project Lead

Ipsen • Cambridge, MA

9d • Remote

About The Position

The Medical Writer Project Lead is responsible for producing consistently high-quality clinical documentation and is able to contribute seamlessly across multiple accounts and projects. As the scientific expert for assigned therapy areas, this individual skillfully integrates strategic insights into deliverables while also providing guidance to colleagues. In this role, the writer will develop regulatory documents for submission to global health authorities across clinical and safety domains. Working with minimal oversight, the Senior Medical Writer owns the full delivery of these documents and collaborates closely with key content leaders across relevant functions. The position also applies strong project management skills and contributes to operational excellence through effective process management. In addition, the Senior Medical Writer plays an important role in mentoring and supporting other writers, helping to elevate overall team capability and quality.

Requirements

• 5+ years of experience in clinical and regulatory medical writing within pharmaceutical, biotechnology, academic, or CRO settings.
• Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
• Proficient in using Microsoft Office programmes (e.g. PowerPoint, Excel, etc.).
• A keen interest in working and developing scientific expertise across a range of therapy areas.
• Flexible approach to working, with the ability to reprioritize and work under pressure when needed.
• Excellent time management skills and demonstrated ability to forecast and manage workload.
• Experience as a clinical/regulatory/safety Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts.
• Able to manage coordination responsibilities beyond writing individual documents, e.g., timelines, reviews and submissions.
• Life sciences degree, preferably MSc or PhD, or equivalent combination of education and experience.
• Recognized industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations).
• Fluent in English.

Nice To Haves

• Previous experience in a medical communications agency or industry is a plus.
• French is a plus.

Responsibilities

• Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules
• Lead Writing/Editing complex Clinical Dossiers/Safety Reports
• Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier
• Plan and create timelines to produce assigned documents
• Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team
• Actively contribute to best practices and continuous improvement within the therapeutic Area
• Represent the group in functional and cross functional initiatives/projects when required
• Network and share best practices to ensure efficiency and consistency across product teams
• Able to work across multiple projects and accounts simultaneously
• Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work
• Adhere to the quality control process and ensure all work produced has gone through the correct internal review process
• Demonstrate a good understanding of project management and resource planning
• Maintain a working knowledge of pharmaceutical industry standards and compliance
• Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested
• Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget
• Understand the purpose and role of communications in the wider therapy area and commercial landscape
• Demonstrate the ability to communicate clearly to different audiences through a variety of media (print and digital)
• Identify and communicate important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate. Link this with any potential new business opportunities where applicable
• Provide regular feedback to senior teams across accounts and projects
• Mentor less experienced medical writers
• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements.
• Participate in mandatory EHS training.

Benefits

• This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.
• At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts.
• Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level