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: Senior Medical Writer-1617579
RESPONSIBILITIES
- Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical and/or technical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience.
- Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed. May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development.
- May present on standard medical and/or technical writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on medical/technical writing to other Quintiles groups.
- May act as Project Manager for a small stand-alone medical and/or technical writing project (e.g. protocol or CSR).
- May coordinate medical and/or technical writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
- Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.
- May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. In-depth knowledge of the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients.
- 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 or pharmaceutical work and/or interpretation of their results.
- Understanding of the time needed to perform routine medical and/or technical writing tasks in order to agree on 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 a protocol or report. Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output as related to acceptance criteria according to SOPs.
- Developing skills in providing effective and sensitive written and verbal feedback to junior staff, and to customers when appropriate.
- Confident and effective communication and negotiation skills with customers and project managers.
- Developing skills in chairing small meetings.
- Ability to work on several projects at once while balancing multiple and overlapping timelines.
- Ability to assess and prioritize workload.
- Demonstrated abilities in collaboration with others and independent thought. Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW).
- Careful attention to detail and accuracy. Must be computer literate. Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in a life science-related discipline, communications, technical writing, or related field, with at least 5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and/or method validation and study data reports; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
1). Extensive use of telephone and face-to-face communication requiring accurate perception of speech
2). Extensive use of keyboard requiring repetitive motion of fingers
3). Regular sitting for extended periods of time
4). May require occasional travel.
Additional Information:
Location: Karnataka-Bangalore
Job Id: 1617579
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Medical writer
Last date : 10th Sept, 2016
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