Associate Director, Medical Writing

The Cameron Craig Group is an executive search firm representing job openings in virtually every industry and job function across the country. We combine the efforts of over 1200 recruiters throughout the US. Together, we represent thousands of job openings and enter dozens of new jobs per day.

The Sr Manager/ Associate Director, Medical Writing will be responsible for writing and overseeing the writing of various clinical and regulatory documents and peer-reviewed scientific publications, including distribution of work to contract medical writers or agencies as needed. This is an individual contributor position with team leadership responsibilities. The Sr Manager/Associate Director Medical Writing will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The core duties of the Sr. Manager/AD medical writing are delineated below.

* Write, manage and oversee the writing of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books) * Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) * Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards * Distill large amounts of clinical and scientific data into essential elements for graphical display * Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams * Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses. * Formulate key messages from clinical study data * Perform literature-based research to support writing activities * Develop best practices for authoring and reviewing * Develop and maintain templates and outlines for key documents

* BS, MS, or doctorate in a scientific or medical field * Five+ years in the biotechnology/pharmaceutical industry preferred * Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus. * Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices * Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support * Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects * Proven ability to develop and implement medical writing processes and standards * Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues * Flexible; adapts work style to meet organization needs * Strong organizational abilities and experience in a multitasking environment * Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals * Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus) * Ability to build and maintain effective partnerships, both internally and externally * Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels * Rare disease experience and a strong understanding of metabolic genetics a plus