Ref #: 26775

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 09-Mar-2021

Description

Typical Accountabilities:

Within Medical Communications, we provide expert communications leadership to drug projects and author strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.

For projects in late clinical development, the Senior MCS authors clinical components of regulatory submissions seeking marketing approval and other clinical-regulatory documents (eg, pivotal CSRs, Module 2.7 summary documents, briefing documents and regulatory response). They work primarily at the document development level, but can contribute to larger strategic pieces of work including the clinical Submission Communication Strategy (cSCS).

For projects in early clinical development, the Senior MCS focuses on authoring and reviewing clinical regulatory documents at the study and drug program levels (pre-IND briefing documents up to and including phase III CSPs). This person is often expected to oversee the medical writing activities across several drug programmes simultaneously, including documents authored by external service providers/contractors.

Across early and late, the Senior MCS is expected to:
• Lead the authoring of high-quality clinical-regulatory documents by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
• Drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Provide critical review of documents for correctness, clarity, completeness and compliance.
• Proactively collaborative with other functions during document development, including, as needed, with external service providers/contractors.
• As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• Work independently but often with the guidance and support of more senior members of the group.
• Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Med Comms on drug and non-drug projects, as required.

Experience:
• ≥ 4 years’ relevant writing experience of late phase (Ph2B-Phase 4) study-related and submission-related clinical and regulatory documents
• Mandatory: Experience of writing protocols, CSRs, patient narratives, IBs, M2.7s CTD summaries, Briefing Documents, and responses to Health Authority questions
• Desirable: Experience of writing m2.5 CTD Clinical Overview and other regulatory documents
• Experience of writing relevant documents for ≥ 3 drug products in Oncology and Immuno-oncology
• Leading the delivery for individual documents, setting clear expectations for completion of assignments to expected timelines and quality.
• Leading scientific discussions within assigned documents and driving the clinical interpretation of data and information and condensing it into clear, concise and accurate messages.
• Engaging proactively and effectively with document stakeholders, navigating their different viewpoints and objectives.
• Anticipating issues and proposing effective solutions for individual documents, escalating as needed.
• Leading and facilitating effective meetings.

Knowledge:

• Serve as a knowledgeable resource on regulatory requirements (eg, GCP, ICH, CTD) and internal/external guidelines relevant for MCS.
• Understand the role of other functions in document development (e.g. statistics, clinical, regulatory, safety, etc.)
• Understand complex clinical study design and statistical concepts, terminology, and analyses within text and tables/figures.
• Is proficient with document and content management systems (e.g Documentum) and with relevant IT software packages (e.g. Word, PowerPoint, Excel, MS Teams)


Interpersonal Skills & Behaviour:
• Has strong communication skills: understands their audience and can convey information effectively.
• Self-motivated and can manage own time effectively.
• Able to manage multiple tasks and deliver on priorities.
• Assertive with good influencing skills
• Attentive to detail
• Able to work effectively under pressure
• Willingness to learn and be open to new ideas (e.g. has a growth mindset)
• Builds positive and productive relationships and trust with colleagues, stakeholders and vendors.
• Models team environment behavior that respects open dialogue and diversity of thought and opinion.