Global Medical Writing Manager

About this role

Responsibilities

• Leadership / Management
• Proactively collaborates within their assigned study/project teams to ensure all medical writing deliverables for a given study 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 ensure team awareness of developments impacting medical writing standards.
• Determine resource needs based on workload and project priorities and communicate to the Head of Biometry in a timely fashion.
• Main Medical Writing responsibilities
• 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.
• Proactively collaborate with study teams (global and local) and other functions including but not limited to therapeutic area, 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.
• Reviews documents to ensure compliance with documentation quality standards and regulatory requirements.
• 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.
• Project Deliverables
• Plan, schedule and track all assigned medical writing activities in close cooperation with clinical operations and medical/regulatory study team members.
• Deliver assigned documents on or before deadline, promptly alerting study / project teams and Head of Biometry of any anticipated delays, information gaps or potential shortcomings in quality.
• Identify Medical Writing process improvement opportunities and contribute to development /maintenance of operating procedures to aim for excellence in execution and delivery.

Requirements

• Life sciences degree, preferably MSc or PhD
• Strong Medical Writing experience in either a CRO or pharmaceutical company.
• RWE Medical writing experience.
• Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.
• Experienced writer of clinical protocols (IS and NIS), study reports (IS and NIS), regulatory dossier level documents.
• Ability to present information in a clear, accurate, logical and non-technical manner. Solid understanding of the
• target audience needs.
• Committed to data integrity and reporting standards.
• Demonstrated ability to assimilate knowledge and understanding of a new therapeutic area.
• Experience managing medical writing projects within a predominately outsourced model, or leading remote based
• medical writing teams (internal or external).
• Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
• English fluency
• If you feel that this could be the right next step for you, we would be delighted to engage with your application.
• Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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: Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases. Why Ipsen? Patient-Focused : The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy. Employee Care : We care for our employees, who are the ambassadors making a real difference. Bold Leadershi p: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions. Growth Opportunities : We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization. About the Role: The Medical Writing Manager is an effective team leader capable of working efficiently with minimal oversight and direction within an asset centric matrix organization. And is the scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others.