Senior Medical Writer

p strong About the role /strong /p br Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today. br p An exciting opportunity has arisen for a highly experienced, proactive Senior Medical Writer, with strong project management skills, to join tranScrip Ltd; a highly specialist pharmaceutical consultancy that provides strategic expertise, therapeutic experience and operational excellence across the entire product lifecycle, supporting clients globally. /p p This is a dynamic role with an extremely varied workload in a rapidly expanding company. Responsibilities include project writing and requires a flexible individual who can adapt to client priorities. /p p strong Duties and responsibilities /strong /p ul li Be able to understand and interpret study designs and clinical trial data. /li li Be able to multi-task, usually working on more than one project at any point in time and have non-project responsibilities. /li li Work with a wide variety of Clients and tranScrip’s therapeutic and development teams. /li li Willing to take on non-project responsibilities such as: /li li Identification, interview and recommendation of excellent subcontractor Medical Writers. /li li Proactive support managing medical writing subcontractor project work from a scope, quality, time and cost basis. /li li Support to scope, cost and ensure quality of client proposals. /li li Leadership or support of key business initiatives. /li li Lead or support training to the company. /li li Assist project teams and colleagues on a planned or ad hoc basis. /li li Train and mentor junior members of the team. /li /ul p strong Experience /strong /p ul li Have experience preparing a wide range of high-quality regulatory, clinical, and scientific content documents across a diverse array of documents including regulatory dossier elements, protocols, clinical study reports, briefing books, investigator brochures etc (Some medical communication work may also be required). /li li A minimum of 5 years’ experience as a Regulatory Medical Writer in the pharmaceutical/biotech industry, ideally in a CRO environment (10 year’s experience would be advantageous). /li li Experience in a wide range of indications would be advantageous. /li li Proven track record in preparing clinical and regulatory documents without supervision. /li li Proven track record in cross functional management of teams for document development. /li li Proficient use of Endnote and internet searches including PubMed an advantage. /li li Excellent project management and planning skills, able to manage budgets. /li li Experience and willingness to support BD efforts. /li /ul p strong Qualifications /strong /p ul li Life science degree, preferably a higher degree (e.g. MSc, PhD). /li /ul p strong Personal attributes /strong /p ul li Self-motivated in both terms of personal development and project work. /li li Flexible and willing to adapt, in a fast-changing environment. /li li Able to work well under pressure. /li li Pro-active, with excellent time management. /li li Good analytical/strategic skills. /li li Good knowledge of local and national guidance and regulations relevant to medical and regulatory writing. /li li Outstanding written and oral communication skills. /li li Excellent level of IT literacy (particularly with Microsoft Office suite). /li li Good interpersonal skills and team-working capabilities. /li li Able to travel, if needed (minimal expected). /li /ul p strong Benefits /strong /p p This is a fantastic opportunity within a rapidly growing company offering excellent benefits including: /p ul li Permanent contract of employment. /li li Competitive base salary. /li li Bonus scheme. /li li Pension scheme. /li li Life assurance. /li li Group income protection. /li li Private health insurance and travel insurance. /li li Retail discounts. /li li Strong focus on CPD. /li /ul p strong Location /strong /p ul li The position of Senior Medical Writer will be office-based but some home-working, a genuine possibility for the right candidate. /li li Remote possible. /li /ul