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At Thermo Fisher Scientific, you will 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.
Summarized Purpose:
We are excited to be expanding our Medical Writing FSP Team in India! We are looking for a Program Manager to be dedicated to a client in the FSP space; experience in Structured Content Authoring systems and AI-driven content creation would be preferred. This role is dedicated to supporting groundbreaking innovative solutions in medical writing. As a Program Manager you may also lead client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management. As a program lead you will oversee planning, monitor, and adapt, client and program-specific processes including new technology implementation.
Essential Functions:
- Serve as a subject matter expert who collaborates with functional stakeholders to adapt digital technologies that will add efficiency in medical writing process and ensure high quality document content that is compliant with industry regulation.
- Expertise in innovative technological solutions for the preparation of medical writing documents, aimed at enhancing cost efficiency, quality, and time management.
- Coordinate the planning, execution, and monitoring of technology implementation, ensuring that project deliverables are met on time.
- Collaborate with medical writing experts and professionals from different teams to ensure solutions meet the highest quality medical and compliance standards.
- Act as a technology ambassador, assisting users with training/onboarding.
- Take a lead and help in the development of new SOPs and learning modules for technology implementation.
- Suggest improvements, identify gaps, and gather feedback from users for continuous improvement of automation tools.
- Manage system validation and contribute to innovation strategies for the Medical Writing team.
- Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations.
- Serve as point of contact for risk escalation. Evaluates and appropriately escalates or resolves risks to project quality.
- Provide training for medical writers on processes and technical aspects of program management.
- May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Experience in managing and directing complex medical writing projects required
Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation.
Experience Working In The Pharmaceutical/CRO Industry Preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) and AI advantageous.
Knowledge, Skills, and Abilities:
- Solid program management skills
- Extensive knowledge of global, regional, national and other document development guidelines
- Excellent interpersonal, oral and written communication, and presentation skills
- Effectively lead study teams through change management
- Excellent negotiation skills
- Self-motivated and adaptable
- Excellent judgment; high degree of independence in decision making and problem solving
- Capable of mentoring and leading junior level staff
What We Offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
