Job Ref: 214942112

Date: 2021-10-19 09:48:14

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The Director of Medical Writing and Quality Control is responsible for managing medical writing and quality control activities in accordance with client and ProPharma Group specifications in a timely, accurate, and efficient manner, to the highest possible written, scientific, and ethical standards in accordance with applicable global industry standards, including ICH and GCP.

Essential Functions Include:

* Manage consultants and vendors, as assigned.

* Lead cross functional coordination of consultants to manage medical writing and quality control deliverables.

* In conjunction with the VP and/or Sr. Director of Medical Writing, define and manage medical writing and quality control deliverables and resource needs, and communicate with recruiting and business development in a timely and effective manner.

* Manage medical writing and quality control clinical program documents (such as protocols, investigator’s brochures, informed consent forms, patient narratives, clinical study reports, eCTD summary documents, and various regulatory documents from Pre-IND stage to NDA submission) for assigned clients.

* Draft medical writing documents and perform thorough document reviews, as required.

* Ensure appropriate communication on medical writing and quality control project and program-related matters with VP and/or Sr. Director of Medical Writing, internal functional heads, and consultants.

* Ensure medical writing deliverables are high-quality and meet ProPharma Group and client standards.

* In conjunction with the VP and/or Sr. Director of Medical Writing, establish working relationships with internal ProPharma Group teams and client project teams to manage medical writing and quality control deliverables.

* Work with the VP and/or Sr. Director of Medical Writing and other functional areas on the continuous development/improvement of medical writing and quality control processes to ensure that work is uniform, complete, and managed appropriately.

* Serve as support to the VP and/or Sr. Director of Medical Writing for Business Development efforts (capabilities meetings, bids/contracts, proposal development, and bid defenses).

* Assist in implementation of goals within medical writing.

* Ensure accurate billing of time to projects; provide oversight of consultant time recorded in ProPharma Group and client time tracking systems, approve consultant time, as required

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