98 Clinical Writing jobs in India

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Medical Affairs - Medical Writing**

Position title/level may vary by site or geographic location

**Purpose**:
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.

As healthcare providers are deluged with data and are making choices in an increasingly complex and stressed health system, Lilly Medical Affairs is able to provide clear, credible answers that will set Lilly apart from its competitors. Medical Affairs’ mission is to make Lilly the preferred pharmaceutical partner in the healthcare community globally by leveraging its medical expertise to drive patient-centric answers and solutions. Medical Affairs (MA) brings deep medical expertise to healthcare providers and payers. MA focuses on answering their questions with customized clinical and real-world evidence that can make the difference on if and how they use Lilly products. Additionally, MA brings clinical insights from customers back to the company to inform new product development and lifecycle planning. MA also supports patients with educational tools to help them manage their illness and with assistance to access our medicines for those facing tough financial situations. The MA content development team will be key in maintaining and creating content to support Medical Affairs activities such as:

- Slide Updates
- Internal Training Slides
- Manuscript Slides
- Data Slides
- Newsletters/ bulletin
- QR Compendium
- Affiliate Regional Slides
- HCP & patient education material
- Advisory board slides
- Competitive landscape slides
- Image sourcing, image redraws
- Lexicon
- MQAD (Medical Questions Analysis Document)

**Primary Responsibilities**:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

**EMS (Executive Medical Summary)**

Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management
- Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
- Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
- Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
- Ensure data are presented in a clear, complete, accurate, and concise manner.
- Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
- Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
- Ensure and coordinate quality checks for accuracy.
- Exhibit flexibility in moving across development and preparation of multiple document types.
- Influence or negotiate change of timelines and content with other team members.
- Work with internal and external experts to develop and prepare presentations.
- As needed, may build and manage relationships with vendors/alliance partners.

Project and Stakeholder management
- Build/communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery
- Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
- Effectively communicate project status to stakeholders

Knowledge and Skills Development
- Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).
- Exhibit flexibility in moving across document types, therapeutic areas, and c

**Job Purpose:**
The Associate Manager, Safety Services (SS), is responsible for supporting aggregate and other allied safety report writing staff, clinical study report (CSR) narratives staff and Signal detection and management (as applicable) in project and/or resource management of SS projects. Where assigned, the Associate Manager acts as Process Manager for designated part of overall process encompassing multiple processes. When applicable, the Associate Manager is responsible for line management of assigned aggregate and other allied safety report writing staff or CSR narratives staff, either at the local site or remotely. The Associate Manager may also support SS management during the sales process by leading client interactions, proposals input, and contract review.
**Key Accountabilities:**
**Accountability and Supporting Activities**
**Line Management (as applicable) and General Management**
+ Supervise and mentor line reports as applicable, including all aspects of SS personnel management: hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, teambuilding, morale, motivation, and supervision of adherence to departmental procedures and health authority guidance and regulations.
+ Validate quality and training compliance.
+ Ensure appropriate billable time for line reports.
+ Undertake the full range of duties relevant to performance management of line reports, when applicable:
+ Situational leadership, including delegation, empowerment, and accountability.
+ Influence and guidance to ensure their performance meets or exceeds both the business and their own personal goals/objectives.
+ Apply measures to retain good employees.
+ Manage low performance through coaching and training; execute performance improvement plans or termination, as required.
+ Attend manager meetings, and chair as invited.
+ Sign off expenses/invoices/purchase orders for expenses, as authorized by SS management
**Client Liaison/Service**
+ Be aware of client expectations for self and team members/line reports.
+ Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working relationships that promote satisfaction and confidence.
+ Respond appropriately to incidents of dissatisfaction and provide feedback to SS management.
+ In the proposal generation process, provide strategic and project planning intelligence to SS management.
+ Provide an assessment of scope of services for clients with respect to aggregate and other allied safety report writing tasks, including a description of the aggregate reports writing services to be performed and estimated hours for each task. When required, liaise with the proposal team and/or client to ensure that the proposal covers all services required.
+ If called upon, attend business development and proposal meetings to prepare and present to clients.
**Project Management**
+ Set clear objectives for assigned safety services team members/line reports and continuously monitor performance against these objectives.
+ Communicate to SS team members the scope of work, client overall expectations, timeline and project goals, technical information, and input from clients throughout the project.
+ Maintain awareness on progress of ongoing reports.
+ Monitor project timelines on an ongoing basis.
+ Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall project performance, as required.
+ Ensure project integrity including conducting sessions for the team that captures all the key learning experiences from the project effort.
+ Provide project updates to SS management and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements to SS management.
+ Fulfill Subject Matter Expertise role for various topics Contribute to process development/improvement:
+ Ensure appropriate changes in scope are escalated. Be familiar with all Client and SS department standard operating procedures (SOPs) and guidelines, and provide input into regular review of these documents, as applicable. Also be familiar with non-SS SOPs that impact work.
+ Analyze efficiency of work: collect and evaluate metrics to identify need for improvement efforts in processes, staff educational activities, or to better meet client needs. Discuss improvement ideas with colleagues within and outside of SS.
+ Provide guidance to other members of the department on current aggregate and other allied safety report writing guidelines and procedures.
+ Attend internal/external audits as required; respond to audit reports and follow-up on any issues highlighted.
**Author aggregate and other allied safety Documents or CSR Narratives Documents**
+ In line with client requirements, gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize any type of aggregate, and other allied safety report writing deliverable, or any CSR narratives deliverable with/without the need for any supervision
+ or formal training.
+ Author aggregate and other allied safety report writing, or CSR narratives as required.
+ Advise on aggregate and other allied safety report writing, and CSR narratives regulatory issues and submissions, as detailed in current ICH, GVP, FDA, EMA, and other applicable guidelines.
**Signal Detection and Management**
+ Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.
+ Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO
+ Conduct/support signal detection and evaluation activities according to SOPs and guidelines
**Quality Control**
+ Strive to ensure client receive a quality report on time, all of the time.
+ Ensure projects assigned to line reports are completed with quality, according to SOPs, and on time.
+ Provide technical leadership to ensure data presented in the documents follow applicable regulatory guidelines, SOPs, and goals of submission
**Training/Compliance**
+ Keep abreast of new advances in regulatory updates and current industry trends.
+ Develop training materials and present to SS staff to enhance writing quality, efficiency, and project management.
+ Present details of technical courses attended or new knowledge
+ acquired.
+ Provide training and mentoring for SS members.
**General**
+ Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner.
+ Provide short-term 'basic' coverage in the absence of other SS management.
+ Perform other tasks appropriate to a more senior position as required, with adequate support and under supervision. Other roles may be allocated in exceptional circumstances
**Skills:**
+ Excellent interpersonal, negotiation, verbal and written communication skills.
+ A professional and flexible attitude with respect to work assignments and new learning.
+ Motivation to work independently and consistently in a fast-paced, rapidly changing environment.
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
+ Competent working in a matrix environment and values the importance of teamwork.
+ Possesses team leadership skills and is able to identify and evaluate viable options to make
+ decisions in a timely and effective manner.
+ Exhibits logical thinking and sound judgement: able to analyze complex issues using data,
+ logic, and judgment to identify problems, determine root cause, and recommend solutions to
+ resolve and prevent the problem.
+ Possesses a positive attitude and ability to adjust to changing priorities and unforeseen events.
+ Capable of handling confidential issues in a professional manner.
+ High level of commitment.
+ Able to work under constant pressure.
+ Demonstrates a client-focused approach to work. Establishes a connection with the client, to gain repeat business and/or to widen existing scope and services.
+ Ability to gain trust and confidence within the company.
+ Provides departmental expertise and perspectives to promote prospective business opportunities; provides Parexel colleagues with pertinent information to formalize a sound business strategy.
**Knowledge and Experience:**
+ Related Experience in management of Pharmacovigilance/ aggregate and other allied safety report writing projects or equivalent.
+ Demonstrated understanding of drug safety, the drug development process, and applicable regulatory guidelines and regulations.
+ Project management experience (e.g., planning and monitoring).
+ Business awareness/business development experience.
+ Advanced word processing skills, including Microsoft (MS) Office (expertise in Word and competency in Excel); software and systems knowledge or ability to learn and adapt to various
+ IT systems: document management systems, collaborative authoring (e.g., SharePoint), and
+ file conversion and databases (e.g., MS Access).
+ Ability to travel.
+ Fluent in written and spoken English.
**Education** :
+ Science/Medicine degree: The minimum qualification required would be a university degree in life
+ Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
+ A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.