Sr Manager Medical Writing

Work Schedule

Environmental Conditions

Job Description

Join Us as an Sr Manager Medical Writing - Make an Impact at the Forefront of Innovation
The Associate Director Medical Writing oversees the regional Medical Writing staff and projects ensuring the delivery of quality products within agreed timelines. This role involves assisting in the development of the Medical Writing organizational structure as well as recruiting training and motivating staff to achieve performance excellence. Additionally the Associate Director helps develop and manage regional operating budgets and identifies new business opportunities and Medical Writing projects. The Associate Director collaborates both internally and with external clients to resolve complex problems and meet client deliverables and needs. Furthermore the Associate Director leads operational excellence initiatives and drives process improvements within the department.

What Youll Do:
Manage the operation of a Medical Writing group to include management of workload departmental resources and allocation of staff to projects recruitment development training performance and personnel issues for managers and writers.
Engage and motivate staff communicate departmental goals and priorities.
Monitor spending against departmental budget and manages to the budget allocated.
Identify need for and promote development of new departmental processes or standards.
Provide oversight of projects led by direct reports and are first line of escalation for project risks. Advise direct reports on contract and budget issues for complex projects; assist in identifying out of scope project support in a timely manner. Participate in project Launch Meetings Review Meetings Project Team meetings and audits as required.
Assist business development and senior management in securing new business by preparing and making presentations to clients. Identify and develop business opportunities involving new Medical Writing projects. Manage the pricing of projects for Medical Writing.
Build relationships with other departments and seek opportunities to collaborate with other functions for mutual benefit (e.g. Phase I medical writing PK biostatistics PVG regulatory). Actively support a changing environment and provide creative novel ideas for taking the organization forward.
Provide leadership in handling complex client management issues. Address and resolve or escalate complex issues and risks to senior management if appropriate. May prepare complex documents and provide senior review.
Maintain knowledge and understanding of PPD SOPs Client SOPs/directives and current guidelines regarding clinical trials documents and other submissions and provide guidance to others as needed.


Education & Experience Requirements:
Bachelors degree in a science-related field required; Advanced degree (PharmD PhD Masters) preferred
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 10 years) or equivalent and relevant combination of education training & experience.
5 years of management responsibility
Proven leadership skills
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills Abilities:
Strong leadership skills with the ability to manage people including performance training mentoring directing and motivating staff
Excellent project management skills including the ability to plan and manage projects develop timelines allocate resources and forecast departmental workload
Excellent knowledge of global/regional medical writing/regulatory requirements for clinical trials marketing authorization and late phase procedures with in-depth knowledge in a specialty area such as preclinical therapeutic regulatory submissions.
Knowledge of budgeting forecasting and departmental and project finances
Excellent understanding of business principles including contracts and proposals
Innovation and leadership in developing new ideas related to Medical Writing including process improvements
Excellent communication negotiation and presentation skills to represent the department in a range of situations including bid defenses capabilities presentations and audits and to communicate influentially with clients corporate leaders and across functional areas
Excellent interpersonal skills including problem solving judgment and decision-making skills.


Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations frequent travels both domestic and international.

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.