Associate Director, Global Medical Writing

Summary

Join Ascendis Pharma as an Associate Director, Global Medical Writing, contributing to the development of new therapies. Based in Palo Alto or remotely, you will report to the Director, Global Medical Writing and collaborate with cross-functional teams. Key responsibilities include writing publications, presentations, and other materials, ensuring compliance with Good Publication Practices. You will interpret clinical data, communicate complex information clearly, and lead project meetings. This role requires an advanced degree in Life Sciences and 8+ years of medical writing experience, along with a strong understanding of relevant guidelines. Ascendis Pharma offers a competitive salary, comprehensive benefits, and professional development opportunities.

Requirements

• Advanced degree in Life Sciences (PhD, PharmD, MS degree) required
• 8+ years previous experience in medical/scientific communications and medical writing (agency or in-house) required
• Understanding of ICMJE, ISMPP, and GPP guidelines for medical writing
• Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
• Understands and effectively responds to multicultural communication styles and business practices with vendors, partners, and internal colleagues

Responsibilities

• Demonstrate a command of therapeutic areas and expertise with assigned products in growth hormone deficiency, hypoparathyroidism, achondroplasia, and new therapeutic areas in development
• Independently research and write original content for publications activities (primary and review manuscripts, abstracts, posters), slide presentations, and other materials using a variety of clinical documents such as protocol, statistical analysis plan, CSR, and TFLs
• Lead internal and external author reviews of documents and effectively manage the editing and revision process
• Demonstrate the flexibility/adaptability necessary to collaborate with and interpret input from various functional teams, including Clinical, Biostatistics, Regulatory, and Legal
• Research, develop, and write content that is scientifically accurate, evidence-based, grammatically accurate, referenced using appropriate sources, and consistent with quality and regulatory standards
• Interpret and apply clinical data in medical and scientific communications deliverables
• Clearly communicate medical scientific concepts in a condensed, audience-appropriate way
• Demonstrate aptitude for technical writing, specifically writing related to medical devices
• Stay updated on industry trends and publication guidelines to enhance writing quality
• Maintain compliance with relevant guidelines and quality standards throughout the document development process
• Lead project meetings and strategic discussions regarding content development
• Participate in or lead strategic publication planning discussions in collaboration with the Publication Lead
• Provide input for development of clinical documents, including protocols, TFLs, statistical analysis plans, and clinical study reports, for scientific rigor and storytelling
• Contribute to department initiatives/activities to improve publications practices and processes
• Mentor junior writers and provide guidance on best practices in publication writing
• Represent Publications in various Medical Affairs functional meetings for assigned therapeutic areas, as needed

Preferred Qualifications

• Prefer prior experience in technical writing, specifically related to medical devices
• Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
• Mastery of referencing programs including Endnote or equivalent
• A high level of initiative and self-motivation
• Substantial drive and goal orientation
• Excellent presentation skills, written and verbal communication skills
• Proficiency with electronic document management systems (e.g., Pubstrat)
• Proficiency in understanding statistical analyses and interpretation of clinical data

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents