Director, Medical Writing Lead, Rare Disease

Job description

Title: Director, Medical Writing Lead, Rare Disease Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: WHAT - Summary & Purpose of the Position The primary responsibilities of the Director, Medical Writing Lead are to establish strategies within the assigned Therapy Area that drive clinical study and regulatory document authoring to the highest quality and regulatory standards. This is a hands-on role that requires the Medical Writing Lead to independently write or direct the writing of medical and regulatory documents. The role manages internal and external medical writing resources assigned to support document development and leads medical writing activities for US, European and other regulatory submissions as assigned. The Director, Medical Writing Lead is responsible for ensuring that data is presented and documents are written objectively in a clear and concise format that can withstand examination by regulatory bodies. The individual is accountable for their own work and for the work of assigned medical writers to ensure documents are prepared, reviewed and approved in a quality and timely manner. The role is also accountable for staying within assigned medical writing budgets and for overseeing all medical writing tasks delegated to external medical writing service providers. WHAT - Main Responsibilities & Technical Competencies Leadership / Management:The Medical Writing Lead is an effective team leader capable of working efficiently with minimal oversight and direction within an asset centric matrix organization. Proactively collaborates within their assigned study/project teams to ensure all medical writing deliverables for a given study and targeted submission plan are prospectively identified, included in the project plan, adequately resourced and are delivered on time and to quality expectations. Directly oversee, develop, and manage medical writers or medical writing service providers; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers Contribute to building capabilities and technical skills across the medical writing department. Stay up to date on regulatory expectations in regards document content for study and submission requirements and ensures team awareness of developments impacting medical writing standards. Determine resource needs based on workload and project priorities and communicate to the Head of Medical Writing in a timely fashion. Work with the Head of Medical Writing to develop contingency plans to address the business needs based on current therapeutic area projects and anticipation of future therapeutic area projects. May serve as back up to Head of Medical Writing at leadership meetings. Medical Writing:Lead by example, serving as an expert document author and directing and supervising the authoring of documents within the framework of and in compliance with ICH-GCP, applicable regulatory guidelines, R&D SOPs and other Ipsen policies. Conducts searches of scientific literature to place study design considerations and study results in context with other relevant data. Proactively collaborate with study teams and other functions including but not limited to regulatory and pharmacovigilance, to ensure assigned documents are developed with medical writer input as early as possible. Lead document strategies and messages in a collaborative way with relevant project team subject matter experts. Perform critical content reviews, correctly interpret results, identify potential limitations and discuss unexpected findings. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Collaborate with quality lines and relevant study team subject matter experts, to ensure the accuracy and quality of information presented in assigned documents. Contribute to formation of key messages in consultation with functional area experts (e.g. Recommending data outputs for collection of specific data, proposing document strategy for filings or responding to health authority requests). When leading a team of other authors (internal or external), be accountable for timely delivery of high quality, fit-for-purpose documents to the study team. Critically review documents produced by writers for scientific content and alignment with company position, clarity, accuracy, and consistency. Drive use of the EDMS by all contributors in the preparation of key study documents (e.g., protocols, clinical study reports and investigator brochures). Project Deliverables:Plan, schedule and track all assigned medical writing activities in close cooperation with clinical operations and medical study team members. Deliver assigned documents on or before deadline, promptly alerting study / project teams and Head of Medical Writing of any anticipated delays, information gaps or potential shortcomings in quality. Stay within assigned budget. Quality and Operational deliverables:Identify Medical Writing process improvement opportunities and contribute to development/maintenance of operating procedures. Contribute to identification and qualification of external medical writing services in collaboration with clinical operations, quality and procurement as needed. Participate in regular operational oversight meetings of medical writing services and contribute to evaluation of provider performance. Ensure any quality related deviations affecting medical writing services are identified, reported and remediated. Provide regular status reports and performance dashboards to the Head of Medical Writing. EHS responsibilities:Respect and enforce applicable EHS regulations and procedures. Promote EHS dynamics within teams for the proper functioning of the EHS management system. Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees. Ensure the completion of mandatory EHS training by their team HOW - Knowledge & Experience Knowledge & Experience (essential): 10+ years of experience in clinical and regulatory medical writing within pharmaceutical, biotechnology, academic, or CRO settings. Experience leading, planning, writing, coordinating, and overseeing the clinical dossier for global regulatory filings, including CTD submissions. Proven capabilities as a medical and regulatory writer with experience authoring clinical protocols, study reports, investigator brochures, and regulatory dossier level documents, with a proven track record in relevant therapeutic areas. Substantial knowledge of varied therapeutic areas, regulatory and scientific guidelines, and key statistical concepts. Advanced knowledge of global regulatory submission requirements, document management systems, and other aspects of drug development including nonclinical, pharmacokinetics, and biostatistics. In depth understanding of Good Clinical Practices, FDA regulations, ICH guidelines, and the clinical and pre-clinical pharmaceutical research and development arena.