Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions. Discover Impactful Work:
Effectively manages medical writing projects and regional operations ensuring high-quality and timely delivery of medical/scientific writing products to internal and external clients. A day in the Life:
Provides substantive advice on strategy, regulations and industry best practices demonstrating subject matter and therapeutic area expertise.
Manages the business development and pricing functions of projects for clients or alliance partners and contributes substantially to business development.
Develops, mentors and guides medical writing staff.
Manages medical writers including management of workload, allocation of staff to projects, recruitment, development, training, performance, and personnel issues for managers and writers
Identifies needs and promotes development of new departmental processes and standards.
May lead departmental teams for process improvement and participates in cross-functional process development
May be the functional MW lead for a project and provide support for writing routine or complex documents.
Provides advice and guidance to writers on technical and regulatory aspects of document preparation. Provides senior review of documents.
Serves as first line of escalation for project risks.
Develops and approves project budgets and advises direct reports on contract and budget issues for large complex projects
Manages the business development and pricing of projects for one or more clients or alliance partners and participates in contract negotiations.
Assists business development and senior management in securing new business by making presentations to clients.
Participates in developing and reviewing proposal texts and budgets in collaboration with Proposal & Contracts Development.
Assists with development of contract modifications and liaises with C&PD to follow through on all aspects of contract modification.
Attends relevant FDA, industry and scientific meetings and maintain relationships with industry contacts.
Provides support to direct reports for complex client management issues.
Keys to Success:
Education
Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters)preferred
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.
2+ years of management responsibility. Knowledge, Skills and Abilities:
Knowledge, Skills, Abilities
Broad range of medical writing project experience and knowledge of global regulatory requirements for clinical trials, marketing authorization and late phase procedures and in-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory, submissions.
Excellent interpersonal skills including problem solving, judgment, and decision-making skills
Ability to manage people including performance management, training, mentoring, directing and supervising work, and motivating employees
Strong project management skills, including the ability to plan and manage projects, create and modify project budgets, develop timelines, allocate resources, and forecast departmental workloadStrong communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits
In depth knowledge of departmental processes; ability to identify emerging needs and propose/develop/ implement new or improved processes
Excellent medical writing skills, including grammatical, editorial, and proofreading skills, and the ability to interpret and present complex data.
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
