Planning, coordination and preparation (as needed) of the documents required to support regulatory and scientific writing activities in the Global Respiratory R&D department.

Major duties and responsibilities that are critical and necessary:

Assist in the preparation and electronic publishing of clinical and other documents in support of global clinical research programs and regulatory submissions. The documents include, but are not limited to, IND briefing documents, investigators brochures, protocols, clinical study reports. Duties include formatting, editing, consistency check etc. With proper training and experience, may take on the role of primary writer, as needed

Responsible as a primary user/trainer of electronic publishing systems/archives (eg. EDMS systems or similar systems) that archive clinical and regulatory documents – initiating the document flow, deposit and retrieve documents, manage workflow, remind approvers regarding approval needs to meet the timelines

Assist in managing activities associated with the submission of Clinical portion of regulatory documents to the FDA (eg. NDA). Coordination of submission timelines and projects, assist in electronic publishing activities utilizing a wide array of document management and publishing tools

Primary liaison between Company and external medical writing vendors/contractors. Planning and managing project timelines and overseeing external consultants/contractor deliverables invoices etc. Collect and distribute required documents/content to the external providers to maintain the document preparation timelines. Maintain and create master documents using the discussion points from meetings, discussions etc.

Oversees tracking and maintenance of all medical writing related documents and correspondence, ensuring outputs are fully documented in accordance with Company SOPs and compliant to regulatory review.

Primary resource for formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic)

Prepare, format and organize power point presentations for managers using a slide deck or other scientific sources

Assist in the preparation of manuscripts for peer-reviewed publications of NDA-targeted clinical studies, and assists in the preparation of abstracts and poster presentations - in terms of formatting, editing, consistency check etc.

Any other task assigned by direct manager

Travel: Approximately 5% or less if needed.

Reports to: Associate Director, Clinical Research

Education and Knowledge:

Education Required: BS/BA or equivalent. Combination of education and related work experience required. Prefer experience as a Medical Writer/coordinator in a pharmaceutical industry environment or related area.

Specific Experience Required: Scientific/technical/medical writing support activities. Should be proficient in Microsoft Word, Excel, Power point and other related soft wares that are used in standard medical writing activities