Director, Medical Writing Lead, Rare Disease

Ipsen•Cambridge, MA

3d•$177,000 - $259,600

About 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.

Requirements

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.
Demonstrated ability to rapidly assimilate knowledge in new therapeutic areas.
Ability to present information clearly, accurately, logically, and in a non-technical manner, with a solid understanding of target audience needs.
Well-honed verbal, nonverbal, and listening skills for problem solving, negotiation, and decision making; patient and open to critique.
Highly organized, proactive, respectful of metrics driven timelines, and accountable for quality; used to managing multiple priorities.
Operational project management experience including planning, prioritization, problem solving, and strong diagnostic, analytical, and process improvement skills.
Experience managing medical writing projects within a predominately outsourced model or leading remote based medical writing teams (internal or external).
Accepts responsibilities, delegates efficiently, and maintains accountability.
Cross cultural understanding and sensitivity; ability to represent the company professionally.
Ability to see the big picture while maintaining attention to detail.
Ability to take initiative with a positive attitude in all circumstances.
Proficient with MS Office Suite (Excel, Word, PowerPoint), MS Project, and experienced with document management systems.
Graduate Degree (Masters or Doctorate preferred) in a relevant scientific discipline required.
Fluent in English.

Nice To Haves

French is a plus.

Responsibilities

Establish strategies within the assigned Therapy Area that drive clinical study and regulatory document authoring to the highest quality and regulatory standards.
Independently write or direct the writing of medical and regulatory documents.
Manage internal and external medical writing resources assigned to support document development.
Lead medical writing activities for US, European and other regulatory submissions as assigned.
Ensure that data is presented and documents are written objectively in a clear and concise format that can withstand examination by regulatory bodies.
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.
Stay within assigned medical writing budgets and oversee all medical writing tasks delegated to external medical writing service providers.
Proactively collaborate 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.
Serve as back up to Head of Medical Writing at leadership meetings.
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.
Conduct 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).
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.
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.
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.