Manager, Medical Writing

The Role:

The Manager of Medical Writing is a key role within our organization, reporting directly to the Associate Director or Director of Medical Writing. This position is responsible for managing the development and delivery of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual in this role will work closely with the clinical development team, understanding and applying medical writing procedures and concepts to develop documents that support the broader objectives of our clinical development program.

Here’s What You’ll Do:

• Functional Knowledge: Understand and apply medical writing procedures and concepts for developing documents within a clinical development program. This includes but is not limited to:

  • Develop and implement departmental strategies: This includes setting goals and objectives for the medical writing team that align with the company's overall strategy.

  • Ensure compliance with regulatory guidelines: The Manager of Medical Writing should be responsible for ensuring that all documents produced by the team comply with international regulatory guidelines and standards.

  • Manage external vendors and consultants: This might include selecting vendors, managing contracts, and overseeing the quality of their work.

  • Develop templates and style guides: This can help ensure consistency across all documents produced by the medical writing team.

  • Provide training and mentorship to team members: The Manager of Medical Writing should be responsible for developing the skills and knowledge of their team members.

  • Participate in cross-functional teams: This can help ensure that the medical writing team's work aligns with the needs of other teams within the company.

  • Work within the established budget for the medical writing department: This includes planning the budget and monitoring expenses to ensure that the department stays within its budget.

  • Stay up-to-date with industry trends and changes in regulatory guidelines: This can help ensure that the medical writing team's work remains current and compliant.

• Problem Solving: Solve problems by identifying and selecting solutions through the application of acquired technical experience, guided by precedents.

• Impact: Contribute to the overall efficiency and effectiveness of the team, through clear communication of performance expectations, handling sensitive issues, and fostering a high-performance culture.

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

• Education and Years of Experience: Advanced degree (preferred) with approximately 3 years of relevant experience OR bachelor’s degree with approximately 8 years of relevant experience.

• Interpersonal Skills: Ability to exchange complex information with others in difficult situations. May be required to guide and convince others.

• Leadership Skills: Ability to mentor junior members of the team (if applicable).

• Business Expertise: Understanding of how own team integrates with others in accomplishing medical writing objectives.

• Quality: Strong commitment to quality and attention to detail.

• Technical skills: Proficiency in medical writing software and a strong understanding of the technical aspects of the job. Proficiency in the use of standard industry software and tools.

Here’s What We’ll Bring to the Table:

• Daily on-site catered lunches [Cambridge] On-site subsidized cafeteria [Norwood]

• Company-provided iPhone

• Free parking, monthly subway pass or a subsidized commuter rail pass

• Free annual corporate membership to Bluebikes

• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP

• Flexible Spending Accounts for medical expenses and dependent care expenses

• 16 weeks of 100% paid parental leave for all new parents

• 16 weeks 100% paid family caregiver leave

• 20 weeks 100% paid medical leave

• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)

• Adoption assistance and discounts to local childcare centers, as well as access to care.com

• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately

• A suite of Moderna paid insurance coverage,