Director, Regulatory Medical Writing - REMOTE

Job Description

The Position

Lead medical writing of clinical regulatory documents for various types of regulatory filings, including but not limited to:  Protocol, Protocol Amendments & CSRs for inline trials, Agency Background Packages and Response to Agency Inquiry, 2.5 Clinical Overviews, Clinical and Non-Clinical summaries and Module 5 documents. Other responsibilities would also include maintenance of common templates and provide content management support (i.e., formatting, citations, content authoring tool workflow facilitation). This position will be required to coordinate routinely with leadership in the Product Registration (Regulatory Liaison) organization, Medical/Clinical/Safety organizations (with CRO), vendor oversight and IT.  

Responsibilities

Interact with therapeutic/functional area leaders to execute on organizational priorities.

Ensures timely and high-quality completion of Medical Writing deliverables that include the proper content and context and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.

Drive interaction and clear handoffs between stakeholder SME organizations (Clinical, Safety, Regulatory, Non-Clinical) to the RMW team.

Support and drive partnering with vendors to provide Medical Writing support.

Lead the development, alignment, and consistent implementation of processes.

Ensures appropriate systems in place such that quality assurance review of documents occurs.

Drive the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents.

Develops and drives process supporting content authoring and formatting to a standard within the global content authoring platform.

Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities.

Provides strategic direction and oversight of multiple contractor (partner) RMW’s composed of senior/experienced RMW and junior RMW roles.

Required Education, Experience and Skills

• Master’s degree in Life Sciences/PhD/PharmD preferred. 

• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.

• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).

• Must have proven track record to be able to think critically, strategically, independently and problem solve.

• Must have high level of motivation, drive, and demonstration of our new company's leadership values.

• Excellent time and project management skills.

• Excellent written and verbal communication skills including ability to write clearly and concisely.

• Top notch interpersonal skills in difficult situations.

• Ability to collaborate across multiple functional areas.

• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations. …