Associate Director, Medical Writing (Fte, Contract, Or Contract-To-Perm)

Amicus Therapeutics, Inc. Cranbury , NJ 08570

Posted 7 months ago

Summary of Position

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

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 programs (development and commercial phases), typically focused within a single therapeutic area or intervention modality (eg, protein chaperoning, enzyme replacement therapy, gene therapy). 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, Program Management, Clinical Research, Clinical Operations, Data Management, and Statistics).

Roles and Responsibilities

Responsibilities include but are not limited to:

  • Serving as the Medical Writing Lead for one or more Amicus clinical development programs

  • Within assigned programs, developing a comprehensive understanding of development plans, study designs, objectives, analysis plans, and results

  • Ensuring that documents 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, results reports, overall summary documents)

  • Performing document-specific tasks such as (a) drafting or overseeing program-level documents such as clinical development plans, IND elements, regulatory designation requests, or investigator brochures (b) Drafting or overseeing protocols, clinical study reports, or other study-specific documents (c) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells, (d) ensuring editorial review of documents (grammar, punctuation, and formatting), and (e) ensuring quality-checking of documents (including submission-ready formatting/internal publishing)

  • 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 Brochures (Initial and/or Updates), Developmental or Periodic Safety Update Reports)

  • Providing status updates to cross-functional colleagues

  • Providing training and guidance on medical writing best practices

  • Ensuring compliance in regard to use of document templates and following standard operating procedures (SOPs), while applying the principle of continuous improvement to all 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)

  • Leading or 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 Requirements

  • 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 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 leading and/or overseeing 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

  • Experience with electronic document management systems and/or collaborative document review tools and approaches

  • Demonstrated high attention to detail, including capacity to catch and resolve issues not caught by more junior level quality checking

Location

  • 1 Cedar Brook Drive, Cranbury, NJ, 08512 or as indicated in the Employment Contract.

Travel

  • 0-5%
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Associate Director, Medical Writing (Fte, Contract, Or Contract-To-Perm)

Amicus Therapeutics, Inc.