Senior Manager of Medical Writing Delivery and Excellence

The Role:The Senior Manager of Medical Writing Delivery and Excellence is a high-impact role, reporting directly to the Senior Director of Medical Writing Delivery and Excellence. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from the meticulous planning and coordination stage to the delivery of the polished final drafts. As our Senior Manager of Medical Writing Delivery and Excellence, you will be more than a team member - you will be a crucial pivot in our clinical development team, deeply understanding and appreciating how your work significantly influences the broader objectives of our clinical development program.

Here’s What You’ll Do:Functional Knowledge:

Apply an in-depth conceptual and practical knowledge of concepts, theories, and principles of medical writing and regulatory writing within a clinical development program.Document Planning:

Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.Project Management:

Oversee the timely and efficient progress of medical writing deliverables, ensuring that all deadlines are met.Cross-Functional Collaboration:

Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents.Regulatory Compliance:

Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards.Data Interpretation:

Interpret and present clinical data and other complex information.Quality Control:

Implement and oversee quality control processes for writing and reviewing clinical and regulatory documents.Document Updates:

Regularly update and revise documents as necessary to reflect current information and meet regulatory requirements.Problem Solving:

Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.Develop and Implement Departmental Strategies:

Provide input into goals and objectives for the medical writing team that align with the company's overall strategy.Line Management:

Responsible for management of direct reports (if applicable).

Here’s What You’ll Bring to the Table:Education:

Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelor's degree with a minimum of 9 years of relevant experience.Industry Experience:

Proven experience in clinical development, regulatory affairs, or medical affairs.Writing Experience:

Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities.Interpersonal Skills:

Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view. Ability to explain difficult or sensitive information; work to build consensus.Leadership Skills:

Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives. Ability to lead functional projects or programs; Mentor and collaborate with colleagues with less experience.Business Expertise:

Knowledge of best practices and how medical writing integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.Communication Skills:

Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.Quality:

Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.Technical Skills:

Proficiency in Microsoft Office and familiarity with medical writing software.

This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.#J-18808-Ljbffr