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Senior Director, Medical Writing

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Primary Location: Reading, Berkshire, United Kingdom Additonal Locations: Amsterdam, Netherlands,NLD; Antwerp, Belgium,BEL; Athens, Greece,GRC; Belgrade, Serbia,SRB; Berlin, Germany,DEU; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Copenhagen, Denmark,DNK; Dublin, Ireland,IRL; Espoo, Finland,FIN; Kaunas, Lithuania,LTU; Ljubljana, Slovenia,SVN; Madrid, Spain,ESP; Milan, Italy,ITA; Oeiras, Portugal,PRT; Oslo, Norway,NOR; Paris, France,FRA; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Sarajevo, Bosnia,BIH; Sofia, Bulgaria,BGR; Solna, Sweden,SWE; Tallinn, Estonia,EST; Vienna, Austria,AUT; Warsaw, Poland,POL; Zagreb, Croatia,HRV Full time R1293194

Job description

"IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Why IQVIA

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients. As a trusted development partner to an extensive range of pharma and biotech companies across the world, working with IQVIA you will hone your specialist regulatory medical writing skills, using your experience of best practices across the industry, and make an impact across multiple therapeutic areas and sponsors.

Forge a career with greater purpose, make an impact, and never stop learning

Job Overview

In a senior leadership position within the business unit, provides strategic and business focused coordination/oversight of Regulatory Medical Writing activities or acts in a customer account management capacity, and leads the setting and direction of strategic business objectives and initiatives. May take a proactive role in approaching, presenting to, and developing a relationship with potential customers. Likely to be a second- or third-line manager with responsibility for a particular area of the business, globally, with financial and/or performance targets. Takes a leading role in ensuring appropriate focus and monitoring of financial performance and forecasts across the business unit. Liaises and collaborates across functions to promote efficiencies, synergies, and cooperation. Provides feedback and guidance to staff on any Medical Writing-related issue. Represents IQVIA Global Medical Writing in all communications, internal and external. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Essential Functions

  • Providing senior leadership and strategic and business focused oversight of Medical Writing activities and lead the setting and direction of strategic business objectives and initiatives.
  • Lead setting and communication of business unit goals, objectives and long-term plans clearly both within Global Medical Writing and the wider organization. May act as a mentor for another manager or senior individual contributor. May plan and deliver internal or external workshops or presentations on Medical Writing topics. May lead/chair a session on Medical Writing related topics at a conference or provide input to/review presentation material of direct/indirect report for presentations on Medical Writing topics.
  • Managing performance of direct reports: set goals and objectives, perform appraisals and propose ratings, propose promotions and bonus, merit and promotional increases, monitor utilization and workload and act accordingly, assign tasks to maximize utilization while considering development goals.
  • Supporting reporting managers in all aspects of performance management. Ensure consistent approach in all areas and consider and adjust proposals as needed to ensure parity and appropriate differentiation across the broader group. Ensure that managers are performing effectively and are providing appropriate support and development opportunities to staff, while also dealing with any performance issues and development needs.
  • Driving, monitoring and optimising financial performance of a significant part of the business versus targets.
  • Identifying new resource needs, including new roles, create financial and practical justifications, job descriptions and specifications. Is creative in considering alternative resource types and models as business evolves.
  • Liaising with customer contacts at a range of levels, dealing with issues, and reaching mutually agreeable solutions. May assist with troubleshooting and advising others in customer relationship or delivery challenges.
  • Leading complex stand-alone Medical Writing proposal development, generating operational and pricing strategy and text, and discussing with other functions as needed. Leading large, complex, and/or strategic partnership/FSP opportunities, and take a leading role in preparing, presenting, and responding in challenging bid defense situations.
  • May propose and/or lead major, global cross-functional initiatives accountable for success

Do you meet the Qualification, skill and expeirnece requirements?

  • Experienced people and business manager, including significant leadership experience in an international Medical Writing business.
  • Experienced in budgeting medical writing deliverables and defining scope of work.
  • Strong track record in identifying and successfully leading major global Medical Writing strategic initiatives and managing change.
  • In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents.
  • Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
  • Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
  • Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
  • Extensive experience in preparing all key Medical Writing deliverables to an exemplary standard, with a track record of successful customer account management, in managing the customer, delivery and financial performance, collaboration across functions, and managing the Medical Writing business.
  • In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
  • Ability to clearly and positively communicate business unit strategy, objectives, and issues to a wide audience and to de-escalate situations through thoughtful, solution-oriented communication.
  • Demonstrated success in making oneself understood at all levels in the organization; behaving professionally and remaining effective in difficult, stressful and/or highly sensitive situations; influencing and motivating others at a high level within IQVIA and customer organizations; excellent judgement/decision making.
  • Able to construct and deliver a case for change using compelling and appropriate language and mode of communication.
  • Exudes confidence and authority within remit and commands respect throughout the organization. Strong leadership skills.
  • Demonstrated success in leading large, complex, and/or strategic partnership/FSP opportunities with independence and confidence.
  • Experienced and effective in providing feedback and guidance to others.
  • Demonstrated financial awareness. Promotes good practices to manage costs.
  • Ability to establish and maintain effective working relationships with co-workers, direct reports, managers and customers at a senior level.
  • Demonstrated abilities in collaboration with others and independent thought to improve processes for project and department operations.
  • Excellent written and oral communication skills including grammatical/technical writing skills.
  • Polished and effective presentation and meeting management skills in a range of challenging situations and audiences.
  • Bachelor's Degree in life sciences related discipline or related field required at minimum, however as M.Sc. or PhD in life sciences related discipline or related field preferred
  • You must have extensive expeirnece within Regulatory Medical Writing, this may be demonstrated by 12 years or more expeirnece.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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