Associate Director, Medical Writing | BioNJ Talent Services

Associate Director, Medical Writing

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Associate Director, Medical Writing works in partnership with the leadership of the Medical Writing Department and is the primary overseer and performer for the medical writing activities that support one or more Amicus clinical development programs. The person(s) in this role will both manage other writers (including Amicus and contract/CRO employees) and work directly on documents/projects with cross-functional teams.

Roles and Responsibilities
Responsibilities, focused on the assigned program(s), include but are not limited to:
Serving as the Medical Writing Lead
Ensuring that documents are appropriate for their target audience while also meeting all regulatory requirements
Managing, leading, and/or assisting more junior writers and other medical writing-related staff (including contract or CRO staff)
Developing a comprehensive understanding of study designs, objectives, analyses plans, and results
Collaborating with subject matter experts across other Amicus functions
< >eading medical writing vendor selection, contracting, and management
Building and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the medical writing community)
Performing document-specific tasks such as (a) Drafting or overseeing clinical study reports, (b) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells, (c) ensuring editorial review of documents (grammar, punctuation, and formatting), and (d) ensuring quality-checking of documents (including for submission-ready formatting)
Ensuring compliance with templates and standard operating procedures (SOPs) and applying the principle of continuous improvement to all in-house and contracted medical writing procedures
Contributing to clinical development team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
Providing training and guidance on medical writing best practices
Participating in departmental oversight, including projection of annual budget and resource needs

Qualifications: 

The ideal candidate will possess a graduate level education
A minimum of 4 to 8 years’ experience with related work within a pharmaceutical company or CRO; all clinical or clinical research experience will be considered

Experience and Skills
Experience across most types of regulatory medical writing deliverables
Must be able to plan activities of self and others, and manage the deliverables of others in accordance with pre-established timelines, while systematically performing activities in a timely and accurate manner
Demonstrated ability to independently make and execute strategic decisions, based on quickly digesting and assimilating pertinent information, and including leading cross-functional teams through execution
Demonstrated ability totranslate technical information from mixed sources into written information suitable for an audience of clinicians and regulatory authorities while summarizing data that enables reaching conclusions and exercising judgment to move projects forward
Training in the biomedical sciences, as well as experience in technical written communication and working cross-functionally, including with partner companies and vendors
Advanced writing and speaking competency
Positive and proactive communication skills, including effective meeting planning and management
Experience in managing junior colleagues, including supporting their career development
Experience in selecting, contracting, and managing contract writers/ writing vendors
Proficiency with the Microsoft Office Suite, including MSProject
Demonstrated high attention to detail, including capacity to catch and resolve issues not caught by more junior level quality checking

Travel
0-5% Travel is required for this position.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Medical