Manager - Medical Writing

Work Schedule

Environmental Conditions

Job Description

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 seeking an experienced and skilled People Manager to join our team in the FSP space. This position involves managing the performance and workload of Medical Writers including short-term and long-term resource planning to assign projects appropriately. Responsibilities include supervising the preparation of deliverables organizing processes to meet timelines evaluating the timeliness and quality of work and acting as a resource for study design adverse event reporting and statistical analyses. The role includes assisting writers with data presentation and interpretation performing peer reviews for adherence to standards participating in SOP and WPD preparation and review and evaluating compliance. Additionally the position involves giving marketing presentations preparing budgets and proposals developing training programs and ensuring adequate training for direct reports.

Key Responsibilities:

• Supervises Medical Writers.
• Supports short-term and long-term resource planning in order to assign projects to appropriate and available staff.
• Holds regularly scheduled meetings with staff and provide updates to senior management.
• Reviews and approves time sheets.
• Assists staff to forecast project-related costs and timelines for completion.
• Supports hiring and evaluation of new employees.
• Recommends salary levels and promotions.
• Supervises the preparation of Medical Writing deliverables.
• Evaluates timeliness and quality of deliverables and provides updates to senior management.
• Acts as a resource for questions relating to study design adverse event reporting and statistical analyses.
• Assists writers in presentation and interpretation of data.
• Performs peer review to ensure overall adherence to departmental standards.
• Supports writing and review of SOPs and WPDs.
• Evaluates compliance with SOP/WPD on an ongoing basis.
• Stays updated on the guidelines and requirements of the ICH FDA and other relevant agencies.
• Gives marketing presentations to potential clients on the capabilities of Medical Writing FSP.
• Interacts with Bids and Contracts and Business Development to support preparation of proposals for Medical Writing projects.
• Develops and maintains training programs for Medical Writing.
• Ensures that all writers are adequately trained.
• Uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data.
• May support writing and coordination of documents for submission to regulatory agencies including INDs NDAs and CTDs.
• Maintains communicates and applies knowledge of current guidelines templates and industry standards.

Education and Experience:

• 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.
• 8 years relevant experience in regulatory medical writing.
• 2 year of leadership (team management) responsibility; longer tenure would be preferable.

Knowledge Skills and Abilities:

• Ability to supervise evaluate and mentor departmental personnel
• Ability to oversee assignments monitor staff workload and provide guidance for completion of assignments
• Ability to create and modify project timelines allocate resources and forecast departmental workload
• In depth knowledge of departmental processes and ability to contribute to improving and developing processes
• Excellent medical writing skills including excellent grammatical editorial and proofreading skills and the ability to effectively interpret and present extremely complex data
• Effective communication negotiation and presentation skills needed to represent the department in a range of situations including bid defenses capabilities presentations and audits
• Ability to develop review and modify proposals and budgets for presentation to clients.

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 with 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 100000 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.