Senior Director, Medical Writing

Senior Director, Medical Writing

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options.

The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence.

The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines.

The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation.

Responsibilities:

• Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals.
• Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization.
• Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents.
• Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials.
• Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines.
• Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices.
• Represent Medical Writing and provide medical writing expertise on cross-functional teams.
• Develop detailed timelines for document development in line with company goals and SOPs.
• Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers.
• Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables).
• Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable.
• Coordinate with the Regulatory Operations team to publish documents that meet eSubmission?ready standards.
• Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates.
• Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations.
• Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable.
• Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines.
• Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC).

Qualifications:

• BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred
• Success in managing resources (internal, external, or hybrid)
• Prior direct experience leading medical writing teams responsible for global marketing authorization applications
• Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle
• Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines.
• Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
• Excellent technical writing and editorial skills; excellent attention to detail
• Strong ability to understand and interpret medical and scientific data
• Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint
• Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote
• Excellent communication, interpersonal, and organizational skills
• Experience working on cross-functional teams
• Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines

Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.