Regulatory Medical Writer

Location

Addlestone, Surrey | United Kingdom

Job description

Regulatory Medical Writer

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

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 an experienced 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 multidisciplinary 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.

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 and with demonstrable relevant experience in the pharmaceutical 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 regulatory 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.

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