Manager, Medical Writing

Job title:

Manager, Medical Writing

Company

Astellas Pharma

Job description

Manager, Medical Writing

About Astellas:

At Astellas we offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a Life Sciences company, our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.

Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword, it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team, or division.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best minds together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

About this job:

Would you like to join an organisation that aims to stand on the forefront of healthcare change, turning innovative science into VALUE for patients? Then bring your unique skills, experience, perspective and thinking ideas to Astellas. We are currently recruiting for a Regulatory Medical Writer to be based in the UK.

You will take the lead on complex and strategic documents including briefing documents for regulatory authorities, IND/NDA/MAA components and responses to regulatory authority queries.

You will work across multiple therapy areas, supporting the overall success of the diverse Astellas portfolio and being an integral member of the Global Medical Writing team. You will be working collaboratively within a multidiscipline working group to achieve shared goals in document related writing activities. This includes drafting documents, co-ordinating and managing the writing tasks.

Understanding complex data is key to this role; you will have an innate curiosity and be able to quickly extract the key messages from the data, understanding the purpose of deliverables, which will empower you to ask the right questions and guide key stakeholders appropriately.

As part of a team working globally, this role can be predominantly home based.

Key activities are noted below:

• Acts as a lead medical writer for complex documents with strategic aspects (generally IND/NDA/MAA components, responses to regulatory authorities, multi-component briefing documents).
• Within a document team, the lead medical writer coordinates, manages and facilitates the tasks necessary for document completion.
• Develops an agreed upon and complete document work plan for the document team, with all needed tasks and subtasks, which enables the team to work efficiently and effectively.
• As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the document team.
• Participates in departmental project activities.
• Collects, monitors, and maintains metrics associated with document creation and quality review, including individual performance evaluation for support writers working on the document team.
• Resolves issues about the use of provided templates and associated document content and established processes.
• Has the experience to implement adjustments in specific document content within framework of provided templates to fit needs of the project.
• May assist a Medical Writing Lead in accomplishing some program tasks for an early-stage development global project.

Essential Knowledge & Experience:

• Educated to degree level or equivalent in a relevant scientific field or having demonstrable experience in a scientific industry.
• Excellent communication and interpersonal skills.
• Demonstrated experience of exercising sound judgment, tact, diplomacy, integrity, and professionalism in all interactions.
• Demonstrated experience of working independently to achieve results with a high degree of accuracy and attention to detail.
• Proficiency in computer systems including MS Word, MS Excel, MS PowerPoint, and MS Outlook

Preferred Knowledge & Experience:

• MS/MA/advanced degree with demonstrated experience as a writing professional in the pharmaceutical industry.
• Technical expertise for several major document types produced by medical writing, including IND/NDA/MAA components.

Additional information:

• The is a permanent full-time position based in the UK.
• This position follows our hybrid working model. The role is predominantly home-based though all our employees are welcome to work from the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Expected salary

Location

United Kingdom

Job date

Wed, 31 Jan 2024 08:17:28 GMT

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