Job Summary

The AD of Medical Writing will independently author key regulatory and scientific documents or oversee external writers in support of activities that span across clinical development and medical affairs. Key documents include clinical study reports, regulatory briefing documents, investigator’s brochure, as well support of scientific presentations and publications in peer-reviewed journals. As a key member of the clinical and cross-functional teams, this position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders. This is a unique opportunity to be an integral part of a pivotal Phase 3 program with contributions towards authoring company critical documents including briefing packages, responses to regulatory requests for information (RFIs), and potential registrational filing.

Job Responsibilities

• Lead planning, authoring, and critical review of regulatory documents as required (e.g., Protocols, CSRs, IB, clinical briefing documents, RFIs).
• Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications).
• Engagement with external stakeholders such as contract writers, vendors,or key opinion leaders.
• Develop and manage timelines for authoring, review and finalization of critical documents and associated delievrables.
• Function as an independent member of the team and represent Clinical Research / Medical Affairs at internal cross-functional or external meetings.
• Other duties related to clinical development of EFX or medical affairs initiatives as assigned.

Qualifications

• Advanced scientific degree in the life sciences (MS or PhD) with 5 years or more direct biotechnology or pharmaceutical industry experience in medical writing
• Prior experience with preparation of clinical protocols, clinical study reports, IB, briefing documents required
• Experience with authoring IND, NDA/BLA/CTD documents or RFI responses highly desirable
• Experience with preparation and submission of posters and peer-reviewed publications is a plus
• Familiarity with hepatology, gastrointestinal, or endocrinology therapeutic area preferred

Technical Requirements and Skills

• Familiarity with GCPs, ICH guidelines and FDA/ EMA/CHMP regulations.
• Ability to compile data, initiate drafts or edit existing documents to deliver high quality products
• Familiarity with using templates and adhering to style guides
• Demonstrated ability to author or oversee regulatory documents (e.g protocols, CSRs, briefing packages).
• Strong interpersonal and communication skills; proactive approach.
• Expertise in navigating scientific literature, interpretation of data, display of data.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously.
• Highly proficient in MS Office Suite (Word, Excel and Power Point).