Remote Senior Manager Medical Writing, Rare Disease

Title:
Remote Senior Manager Medical Writing, Rare Disease

Company:
Clementia Pharmaceuticals USA, Inc.

Job Description:

Are you looking for an opportunity to apply your medical writing experience in a global organization with a focus in bringing new therapies to patients with rare diseases?

As Senior Manager, Medical Writing, you will be responsible for the generation of consistently high-quality clinical documentation content and capable of working across multiple accounts and projects seamlessly. You will be the scientific expert in allocated therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others. In addition to this, you will be responsible for preparing regulatory documents for submission to regulatory authorities within subject area (clinical/safety). Working with minimal guidance, you'll take accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. By applying project management expertise and contributing to functional excellence through process management, you will also play a role in guiding other medical writers.

Your role will involve:

Main Medical Writing responsibilities

• Manages the preparation of a complex suite of regulatory documents including but not limited to CSRs, protocols, briefing documents, meeting requests, investigator brochures, regulatory submission modules, and/or a suite of Safety Documents e.g. RMPs, DSURs, PSURs.
• Leads Writing/Editing complex Clinical Dossiers/Safety Reports
• Reviews documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier
• Plans and creates timelines to produce assigned documents.
• Ensures proper planning and resourcing of all assigned documents
• Actively contributes to best practices and continuous improvement.
• Represents the group in functional and cross functional initiatives/projects when required
• Networks and shares best practices to ensure efficiency and consistency across product teams

Project Delivery

• 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

Communication

• 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

In return, you will bring:

• Minimum of a master's degree in life sciences, medicine, pharmacy or related disciple
• Life sciences degree, preferably MS/MSc or PhD
• Minimum 5 years Medical Writing experience in either a CRO or pharmaceutical company
• Recognized industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations) would be advantageous
• Proficient in using Microsoft Office programs (Word, PowerPoint, Excel, etc.)
• Have an excellent command of the English language in both written and verbal communications desirable
• Previous experience in a medical communications agency or industry would be advantageous
• 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

If this opportunity aligns with your interests and experience, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.