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Associate Director, Medical Writing

Amicus Therapeutics

$131,430.00 - 199,650.00 per year

Full-time

142 Plainsboro Rd

Cranbury, NJ 08512

Position Summary
Amicus Therapeutics is a biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We are looking to hire an experienced medical writing lead to be based at our headquarters in Cranbury, NJ. This Associate Director, Medical Writing will report to the Senior Director of Medical Writing. This individual works in partnership with the senior management 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. The individual will serve as the medical writing expert for a program and collaborate with internal staff across various departments (eg, Global Regulatory Affairs, Clinical Research, Clinical Operations, Data Management, and Statistics).

Roles and Responsibilities
Serving as the Medical Writing Lead for one or more Amicus clinical development programs
Within assigned programs, developing a comprehensive understanding of study designs, objectives, analysis plans, and results
Ensuring that documents prepared are appropriate for their target audience while also meeting all regulatory requirements
Compose, revise in response to team feedback, and deliver submission-ready documents (eg, key clinical study protocols, briefing documents, overall summary documents)
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)
Manage, lead, and/or assist more junior writers and other medical writing-related staff (including contract or CRO staff)
Provide detailed, accurate, and timely reviews of documents prepared by others (eg, Statistical Analysis Plans, Clinical Study Reports, Investigator Brochure Updates, Developmental or Periodic Safety Update Reports)
Providing training and guidance on medical writing best practices
Ensuring compliance in regard to use of document templates and following standard operating procedures (SOPs), including applying the principle of continuous improvement to all in-house and contracted medical writing procedures
Collaborating with subject matter experts across other Amicus functions
Contributing to clinical development team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
Planning and conducting cross-functional meetings
Building and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the overall medical writing community)
Contributing to medical writing vendor selection, contracting, and management
Participating in departmental oversight, including projection of annual budget and resource needs
Keeping informed of new regulations and/or guidance from regulatory authorities
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
Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
Demonstrated ability to translate 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
Requirements
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
Location
This position will be based at 1 Cedar Brook Drive, Cranbury, NJ, 08512
Majority of time (eg, 3 of every 5 days) are to be onsite
Travel
0-5% Travel is required for this position


Associated topics: administrative, administrative support, assist, associate, front desk, operation, operational assistant, operations director, records management, support