Senior Medical Writer

About Perceptive

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.

We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together.

Are you ready to help change the world?

Apart from job satisfaction, we can offer you:

HEALTH:
- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)

YOURSELF
:
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings

WEALTH:
401(k) program, life & accident insurance and disability insurance

A Senior Medical Writer will create, research, edit and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations and supplementary imaging reports, either independently or using available central content and templates. The medical writer will serve as a contact with clients.

• Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities.
• Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
• Draft and/or ghost-write clinical documents for more experienced medical writers
• Act as support to others in the team to ensure that all documentation is accurate and encompasses all relevant information based on Stakeholder needs.
• Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content, and general guidelines for clinical documentation and workflow procedures.
• Initiate and participate in marketing initiatives, such as white paper, abstract, poster, and manuscript development

• Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues.
• Serve as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectations
• Coordinate and conduct interdepartmental team reviews of draft and final documents,
• Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Perceptive and/or client guidelines/SOPs.
• Distribute final documents to project team and client in a timely manner and to agreed timescales
• Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options.
• Attend project team meetings as required.
• Ensure appropriate filing of applicable project documentation
• May provide project management of contractual and financial aspects.

• Implements stakeholder engagement/communications plan.
• Deals with problems and issues, managing resolutions, corrective actions, lessons…