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PAREXEL International LLC Associate Director, Scientific & Medical Writing Services in Billerica, Massachusetts

Associate Director, Scientific & Medical Writing ServicesBillerica, Massachusetts, United StatesDate posted09/15/2020Job ID62471BR

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Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.

  • Full Time

  • Level: Mid

  • Travel: No

  • Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Detail-Oriented

  • Deadline-Oriented

  • Communicator

  • Organized

  • Versatile

  • Tech-Savvy

  • "I am part of a great team! My colleagues at Parexel are a pleasure to work with, are

knowledgeable, experienced, caring and always ready to help!"

Anne-Christin Friedrich - Senior Medical Writer

  • "I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,

knowledgeable, and it is easy to communicate with other staff."

Christine Simmons, Medical Writer II

  • "Parexel makes it easy to communicate and interact with each other, which allows

me access to expertise and knowledge beyond my own."

Kristy Haslerud, Associate Manager

  • "Since the day I started, I have learnt something new from people on my team: it can be something associated with medical writing, the latest technology, or a tool that enhances/ aides writing."

Erangi Tennakoon, Medical Writer II

Rewards

  • Global Impact

We are one truly global team working together to propel each client´s journey ahead faster.

  • Work-life Balance

We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Career Development

Opportunity to learn and grow through a performance and development goal-setting program.

  • Home based

Love where you work, and work where you love.

  • Variety

Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

Responsibilities

The primary role of the Associate Director is to ensure the satisfactory management of medical writing operations in a manner consistent with Corporate and Department mission and goals. Must have FDA Independent Review Charter writing experience and an understanding of imaging criteria within clinical trials. Responsibilities include serving as internal and external representative for medical writing, coordination with other departmental management to harmonize processes, employee development, and management of team; supervision and management of medical writing staff; review of department budget; seeking and following up on medical writing sales opportunities, and leading departmental and cross-functional communications, training, and process improvements. The Associate Director will also have responsibilities as a client liaison or partnership lead and will support medical writing management during the sales process by providing sales input.

Key Accountabilities:

  • Medical Writing Team Oversight - team of 5 - 6

  • Facilitate harmonization of medical writing management.

  • Oversee maintenance of medical writing-related standard operating procedures and guidelines with continual evaluation of systems for improvement.

  • Lead development, and continuous improvement of medical writing training, and career development initiatives.

  • Identify and resolve inter-departmental challenges and issues in a team-oriented environment through cooperative initiatives with other department heads

  • Serve as Chairperson for regular medical writing staff meetings, intra- and inter-departmental information sharing venues, as appropriate.

  • Review current progress/progress forecasts and medical writing department performance against defined metrics.

  • Employ change management be identifying key drivers which will help manage change within and across the region/department, so that all employees are committed to modifications.

  • Supervise and mentor medical writing staff and line managers, including all aspects of medical writing personnel management: job description development and maintenance, hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, and supervision of adherence to departmental procedures and health authority guidance and regulations

  • Undertake the full range of duties relevant to the leadership, management, and development of line reports to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.

  • Provide strategic/technical input to project administration of medical writing projects, from contract development through to closure

  • Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects.

  • Manage assigned customer accounts to ensure their needs are being met to a high degree of service, developing relationships within accounts, and identifying and pursuing new business opportunities with accounts under area of responsibility.

  • In the proposal generation process, provide strategic and project planning intelligence for medical writing activities.

  • Participate as member or leader of departmental committees (e.g., process improvement, standards, partnerships).

Skills:

  • Excellent interpersonal, negotiation, verbal, and written communication skills

  • Several years of management experience

  • 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 team work.

  • Possesses team leadership skills, cross-cultural sensitivity, and can influence without authority.

  • As client liaison, demonstrates a client-focused approach to work and establishes a connection with the client, to gain repeat business and/or to widen existing scope and services.

  • Provides departmental expertise and perspectives to promote prospective business opportunities

QualificationsKnowledge and Experience:

  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.

  • Broad experience in management of complex medical writing projects.

  • Significant previous line management experience, preferably in a billable service industry.

  • Project management experience (e.g., planning and monitoring).

  • Business awareness/business development experience.

  • Advanced word processing skills, including 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.

  • Ability to travel.

  • Fluent in written and spoken English.

Education:

  • Bachelors Degree

EEO DisclaimerParexel 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.

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