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AGTC Medical Writer III/Senior Medical Writer in Cambridge, Massachusetts

Mission The Medical Writer III/Senior Medical Writer for clinical affairs is tasked to write and coordinate basic documents independently and more complex documents (e.g regulatory submissions). The position will function as the lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision of the clinical affairs organization. Reporting Relationship The position reports to the Senior Vice President of Clinical Affairs or designee Duties and Responsibilities Writes or coordinates clinical and regulatory documents such as, CSRs, IBs, protocols, summary documents and regulatory responses of lower complexity. Writes and coordinates clinical affairs documents such as abstracts, manuscripts, posters, and power point presentations. Leads cross-functional (eg, with clinical team) document planning and review meetings. Interacts with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed. Utilizes up to date review and editing software facilitating document completion. Works in a team environment with increasing independence for longer-term activities and takes an active role on assigned projects with respect to timing, scheduling, and tracking. Able to guide or train cross-functional team members on processes and best practices. Regularly meets with manager and mentors and attends departmental meetings. Attends cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings). Maintains and applies knowledge of industry, company, and regulatory guidelines. Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems. Other job duties as assigned This job description is subject to change at any time. Educational Qualifications Bachelor’s degree An advanced degree (e.g., Masters, PhD, MD) is preferred. Additional Qualifications Medical Writer III: At least five (5) years of experience with a combination of relevant pharmaceutical/scientific experience and clinical/regulatory writing experience is required. Senior Medical Writer: At least eight (8) years of experience with a combination of relevant pharmaceutical/scientific experience and clinical/regulatory writing experience is required. Strong oral and written communication skills. Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content, under supervision. Attention to detail. Ability to function in a team environment. Organizes time well. Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves basic problems independently and more complex problems under close supervision. Builds solid and productive relationships with cross-functional team members. Applies knowledge of regulatory guidance documents such as ICH requirements. Physical Requirements Physical demands: (check one) ☒ sedentary (< 10 lbs.) ☐ light work (< 20 lbs.) ☐ medium work (< 50 lbs.) ☐ heavy work (< 100 lbs.) ☐ very heavy work (> 100 lbs.) Physical activity: (check all that apply) ☒ repetitive motion ☐ balancing ☐ stooping ☐ lifting ☐ climbing ☐ kneeling/crouching ☐ crawling ☐ reaching ☐ standing ☐ typing/grasping ☐ walking ☐ pushing/pulling ☐ hearing Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.) Working conditions (indoor/outdoor, noise levels, hazards, working quarters) Supervisor Responsibilities This position does not require previous supervisory experience