Associate Director, Global Medical Writing - Job ID: 1704

Ascendis Pharma • Palo Alto, CA • 1d ago

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

Serving as a link among key functions, the Associate Director, Global Medical Writing ensures that critical scientific information is communicated with clarity, precision, and accessibility. This position will work cross-functionally with therapeutic area teams to prepare manuscripts, abstracts, reviews, posters, reports, presentations, and other materials, and ensure compliance with Good Publication Practices while distilling complex medical information into understandable formats.

This position will be based in Palo Alto or remote and will report to the Director, Global Medical Writing

Key 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

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

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

Salary Range: $170-185K/year DOE

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

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

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