Medical Writing Manager

Description:

• Prepares and reviews clinical/regulatory documents that are high quality, concise, and comply with internal and external standards in support of all phases of drug development.
• Participates as subject matter expert for Medical Writing on product teams, leads the authoring process, works with contractors, and participates in timeline development for documents and New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs).
• Leads the authoring process for a variety of clinical/regulatory documents (eg, clinical study protocols; clinical study reports; investigator brochures; briefing documents; M2 Clinical Summary Documents for INDs, NDAs, and MAAs, PIPs, PSPs; response to regulatory questions; and other regulatory documents as appropriate
• Ability to independently interpret and communicate scientific data
• Represents Medical Writing on project teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Nonclinical, and Regulatory) from a writing and scientific perspective
• Interprets scientific data and interacts with functional leads in data interpretation and positioning in documents
• Leads comment resolution meetings
• Ensures documents are clear, concise, strategic, and well positioned for public disclosure
• Researches, recommends, and participates as a key contributor for implementing best authoring best practices and provides continuous training to teams
• May train / lead lower level staff
• Assist other writers on NDAs and MAAs
• Other duties as assigned

Requirements:

• BS/BA degree in life sciences or related field and 6+ 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 Master’s degree in life sciences or related field and 4+ years of similar experience noted above
• OR PhD in life sciences or related field and 2+ years of similar experience noted above
• Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses
• Ability to communicate data in a manner that is accurate and provides the appropriate understanding of the benefit/risk of a product
• Proven ability to lead teams through the authoring process
• Ability to provide constructive feedback 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
• Experience working with and leading contract medical writers
• Experience with NDA/MAAs or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.) is preferred
• Ability to independently (with minimal supervision) understand, interpret, and communicate scientific data
• Understands the drug development process
• Exhibits leadership through supporting and leading writing best practices with cross-functional teams.
• Strong understanding of the medical writing process, procedures, regulatory requirements, and systems (eg., DMS)
• Ability to meet multiple deadlines across a variety of projects, with a high degree of accuracy and efficiency
• Excellent communications, problem-solving, analytical thinking skills
• Ability to be a supportive, effective, and valued team member

Benefits:

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

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