Sr. Manager, Medical Writing

About the Role:

Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of an interdisciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Lead the writing activities for all regulatory documents for a project team, which include leading the writing process, identifying and managing contractors, planning activities for New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building and managing the submission writing team.

Your Contributions (Include, But Are Not Limited To):

• Authors and manages the authoring process for all clinical/regulatory documents (eg, clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, response to regulatory questions, Pediatric Investigational Plans, and other regulatory documents)

• Leads and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Preclinical, and Regulatory) from a writing and scientific perspective

• Leads data interpretation and comment resolution meetings

• Ensures document content is clear, concise, strategic, and well positioned for public disclosure

• Supports authoring best practices and provides continued training to teams

• Represents Medical Writing Department on project teams

• Mentor, and may manage, internal staff

• Represent Medical Writing on departmental projects and cross-functional teams

• Supports other lead writers on NDAs and MAAs

• Other duties as assigned

Requirements:

• BS/BA degree in the life sciences or related field AND 8+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred. OR

• MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above OR

• PhD in a life sciences or related field preferred AND 4+ years of of experience as noted above OR

• Previous managerial / functional management experience also required

• Proven ability to lead cross-functional teams through the authoring process

• Excellent team player who can effectively navigate differing opinions and personalities

• A leader who works well with others and enjoys a collaborative approach

• Strong skills in leadership, communication and creativity

• Able to work well both independently and as part of a team

• Excellent project management skills, including managing simultaneous projects

• Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools

• Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses

• Strong science background that enables the ability to interpret and communicate scientific and clinical trial data

• General understanding of statistics

• Broad understanding of the medical writing processes, procedures, and systems used to accomplish the team's work

• Proven ability to lead cross-functional teams through the authoring process

• Ability to provide strategic leadership as it relates to communicating and positioning nonclinical and clinical data

• Excellent team player who can effectively navigate differing opinions and personalities

• Excellent understanding of the writing and regulatory process that enables streamlining of content and processes

• A leader who works well with others and enjoys a collaborative approach

• Ability to provide strategic leadership as it relates to communicating and positioning nonclinical and clinical data

• Excellent understanding of the writing and regulatory process that enables streamlining of content and processes