Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics – ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Medical writing manager-1611731
Job Description:
PURPOSE:
Takes a leading role in preparing or contributing to the production of any type of clinical document, for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Acts as mentor for less experienced Medical Writers and assists in their training and development. Participates in project teams and may provide service as an independent expert. May serve as writing lead and project manager for medical writing projects.
RESPONSIBILITIES:
* Acts as Lead Medical Writer on any type of writing project, with limited guidance from senior staff, and consistent high quality and efficiency. Can use experience and initiative to tackle new/unusual document types and customer requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical
* Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. Can provide independent review of budgets and costings for routine projects. Proposes costings for less routine projects, out of scope activities, and potential budget efficiencies, with guidance from manager. May present on project-specific MW proposals at a full-service bid defence meeting (e.g. managing a series of projects to ensure consistency), with management input to slides as required.
* May provide senior review and guidance for most documents prepared by junior staff. May design training materials and input into generic training plans. May plan and deliver general training on Medical Writing to other Quintiles groups and externally, as appropriate.
* May act as Project Manager for a small series of stand-alone Medical Writing projects (e.g. series of related CSRs). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
* May represent region or site on a MW initiative or cross-functional initiative.
* Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
* May propose revisions to SOPs or suggest process improvements for consideration. May draft new MW SOPs for review and act as reviewer for MW SOPs, as assigned and appropriate. All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
• Excellent standard of written English. Ability to communicate fluently and effectively with colleagues and customers in English, both in writing and verbally.
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents.
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions.
• Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority.
• Ability to identify deficiencies, errors, and inconsistencies in documents.
• Ability to effectively review a statistical analysis plan.
• Ability to identify deficiencies, errors, and inconsistencies in statistical output.
• Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
• Confidence in raising and discussing more sensitive topics without management intervention.
• Experienced and effective in providing feedback and guidance to more junior staff.
• Confident and effective chairing of small to medium-sized meetings.
• Ability to understand the customer’s point of view and proactively address customer concerns.
• Ability to work on several projects at once while balancing multiple and overlapping timelines.
• Demonstrated abilities in collaboration with others and independent thought.
• Knowledge of regulations relevant to medical writing.
• Careful attention to detail and accuracy.
• Must be computer literate.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients If you want to make an impact in the global research market, where we’re working to make a real difference in patient health, we ask you to apply now and join our team.
Qualifications:
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s degree in a life science-related discipline, with at least 5 years’ broad-ranging experience as a medical writer within a pharmaceutical environment, including extensive experience in preparing clinical study protocols and reports, with consistently positive customer feedback; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Occasional travel
Additional Information:
Qualification: Bachelor’s degree in life sciences
Experience: 5 Years
Location: Maharashtra-Mumbai
Job Id: 1611731
