Senior Manager Medical Writing Services

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal to improve the worlds 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 were committed to making a difference.

Key Accountabilities:
Accountability
Line Management 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.

o Validate quality and training compliance.
o Ensure appropriate billable time for line reports.
Undertake the full range of duties relevant to performance management of line reports when applicable:
o Situational leadership including delegation empowerment and accountability.
o Influence and guidance to ensure their performance meets or exceeds both the business and their own personal goals/objectives.
o Retain good employees; identify talent and nurture employees to ensure the organization has strong bench strength to compete at the highest levels. 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.
o Build and maintain collaborative client relationships to cultivate efficient productive and professional working relationships that promote satisfaction and confidence.
o Implement measures of performance (key performance indicators) into feedback metrics and continuous improvement activities to optimize performance.
o 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.
o 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.
o If called upon attend business development and proposal meetings to prepare and present to clients.
Provide support as appropriate to Business Development/Client Solutions in their efforts to win new business. Identify and solicit new business leads for SS.
Apply industry experience:
o Understand the challenges clients face and propose solutions on how to overcome such challenges.
o Use awareness of opportunities in the industry to present new possibilities to customers when appropriate.
Project Management

As applicable manage individual partner stakeholder and customer relationships and their performance; manage partnership operations relationships and personnel.
Set clear objectives for assigned safety services team members/line reports and continuously monitor performance against these objectives.
o Maintain awareness on progress of ongoing reports.
o Monitor project timelines on an ongoing basis.
o Provide leadership and strategic planning/adjustments delegation of responsibilities and tasks. Monitor progress of each individual project task and assess the overall project performance.
Provide project updates to SS management and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements to SS management.
Contribute to process development/improvement:
o Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated.
o 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.
o 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.
o Provide guidance to other members of the department on current aggregate and other allied safety report writing guidelines and procedures.
o Attend internal/external audits as required; respond to audit reports and followup on any issues highlighted.
Author aggregate and other allied safety Documents or Clinical Study Report Narratives

Documents/Consultancy
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 endtoend 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 the data presented in the documents are in compliance with 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

Participate as member or leader of departmental committees (e.g. process improvement standards partnerships).
Maintain a positive resultsoriented work environment building partnerships and modeling teamwork communicating to the team in an open balanced and objective manner.
Provide shortterm 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.
Promote the medical writing profession internally or externally.

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 fastpaced 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.
Demonstrates a clientfocused 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.
Ability to act with confidence during demanding situations in the face of opposition challenge or anxiety.

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 is desirable in Regulatory/ Pharmacovigilance or related field.
Demonstrated understanding of drug safety the drug development process and applicable regulatory guidelines and regulations.

Broad experience in management of aggregate and other allied safety reports writing projects

Understanding of people management: previous line management experience or equivalent preferably in a billable service industry.

Project management experience (e.g. planning and monitoring).
Knowledge of resource management and productivity metric management.
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 hospitalbased environment would be an advantage