Associate Manager, Safety Medical Writing

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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